Oncologist. 2026 Jul 20:oyag235. doi: 10.1093/oncolo/oyag235. Online ahead of print.

ABSTRACT

BACKGROUND: Immunotherapy has shown to be efficacious in patients with deficient mismatch repair (dMMR)/microsatellite instability-high (MSI-H) colorectal cancer (CRC). Unfortunately, there is still a population of patients who either do not respond or progress after prior response. Understanding the progression dynamics and outcomes based on the nature of disease progression (PD) is critical in this patient population.

METHODS: We performed a retrospective analysis of 166 patients with advanced dMMR/MSI-H CRC who received immunotherapy. PD patterns were classified as intrinsic (progression at first restaging scan) or adaptive (progression after initial stable/responding disease) and as single organ or systemic.

RESULTS: Progression was seen in 64 patients (38.6%) with single organ progression in 31 (48.4%) and systemic progression in 33 (51.5%). Intrinsic progression was seen in 32 patients (50%) and adaptive progression in 32 (50%). Patients with single organ progression had a longer median TTP (mTTP) and median OS (mOS) compared to patients with systemic progression (mTTP: 8.8 vs 4.0 months, p = 0.005; mOS: 65.9 vs 18.7 months, p = 0.023). Patients with adaptive PD had a longer mTTP and mOS compared to patients with intrinsic PD (mTTP: 11.6 vs 1.9 months, p = <0.01; mOS: 65.9 months vs 17.0 months, p = 0.001).

CONCLUSION: This analysis identifies significant differences in outcomes of patients with dMMR/MSI-H CRC based on the pattern and extent of progression, underscoring the need for tailored therapeutic strategies depending on the nature of PD-1 based progression.

PMID:42475509 | DOI:10.1093/oncolo/oyag235

The post Patterns of Progression and Survival in Patients with dMMR/MSI-H Metastatic Colorectal Cancer Treated with Immunotherapy appeared first on Fight Colorectal Cancer.

Ann Surg Oncol. 2026 Jul 16. doi: 10.1245/s10434-026-20254-7. Online ahead of print.

ABSTRACT

BACKGROUND: In colorectal cancer (CRC)-related carcinomatosis, the risk of ovarian metastases (OM) is not well described, and practices during cytoreductive surgery (CRS) vary widely. Defining this risk is critical for counseling patients on the necessity of oophorectomy during CRS.

METHODS: This retrospective study analyzed female patients with CRC-related carcinomatosis undergoing curative intent CRS with or without hyperthermic intraperitoneal chemotherapy (HIPEC) at a single center (2008-2024).

RESULTS: The study identified 74 patients, 66% of whom were post-menopausal. The median Peritoneal Cancer Index (PCI) was 8 (interquartile range [IQR], 6-10), and all the patients had a complete cytoreduction (CCR 0/1). Right-sided primary tumors were the most common (57%), and the histology was most commonly non-mucinous (n = 51, 69%), moderately differentiated (n = 49, 66%), and microsatellite stable (n = 67, 90%). Neoadjuvant therapy was common (n = 58, 78%), and 25 (34%) of the patients underwent HIPEC. Four of the patients (5%) had undergone bilateral salpingo-oophorectomy (BSO) before the diagnosis of peritoneal disease. Of the 70 remaining patients, 51 (73%) had grossly abnormal-appearing ovaries. Of the 70 patients, 65 (93%) had a bilateral or completion salpingo-oophorectomy, and 2 (3%) underwent a unilateral oophorectomy. Overall, 55 (79%) of the patients had pathologically confirmed OM. Of the 16 patients with normal-appearing ovaries who underwent oophorectomy, 4 (25%) had microscopic OM. Two (40%) of the five patients with normal-appearing ovaries preserved during CRS experienced ovarian recurrence within 15 months.

CONCLUSIONS: Most of the female patients undergoing CRS for CRC-related carcinomatosis had OM, including 25% of the patients with normal-appearing ovaries. Short-interval recurrence was observed with ovarian preservation. Routine BSO should be strongly considered for patients undergoing CRS with curative intent.

PMID:42463608 | DOI:10.1245/s10434-026-20254-7

The post Risk of Ovarian Metastasis in Colorectal Cancer-Related Carcinomatosis appeared first on Fight Colorectal Cancer.

Fight Colorectal Cancer (Fight CRC), a leading advocacy organization dedicated to supporting colorectal cancer patients and caregivers, continues to expand ChatCRC, the first AI-powered chatbot designed specifically for the colorectal cancer community. Since its launch, ChatCRC has evolved beyond answering questions to include new tools that help patients better understand their diagnosis and identify potential treatment opportunities.

ChatCRC provides accurate, accessible, and personalized information related to colorectal cancer prevention, diagnosis, treatment, and survivorship. Available 24/7, the platform helps patients, caregivers, and healthcare providers navigate complex medical information with confidence.

One of ChatCRC’s newest features is the Biomarker Report Reader, which allows patients to securely upload their biomarker testing report. ChatCRC translates complex medical terminology into clear, easy-to-understand language, explains the significance of key biomarkers, outlines how results may influence treatment decisions, and suggests questions patients can discuss with their healthcare team.

In addition, the new Clinical Trial Finder helps patients identify relevant clinical trials by searching ClinicalTrials.gov based on their cancer type, biomarker profile, and geographic location. This feature makes it easier for patients to explore research opportunities that may be appropriate for their individual diagnosis.

Educational content throughout ChatCRC is curated and reviewed by Fight Colorectal Cancer to provide trustworthy, patient-centered information.

“We are thrilled to continue expanding ChatCRC as an innovative resource in the fight against colorectal cancer. By helping patients better understand their biomarker reports and connect with potential clinical trial opportunities, we’re empowering them with information that can support more informed conversations with their healthcare team and ultimately improve their care journey.”

– Anjee Davis, President, Fight Colorectal Cancer

Key features of ChatCRC include:

Biomarker Report Reader
Upload a biomarker or genomic testing report to receive a plain-language explanation of key findings, understand what your biomarkers may mean for treatment, and prepare informed questions for your healthcare team.

Clinical Trial Finder
Search ClinicalTrials.gov for clinical trials based on cancer type, biomarker profile, and geographic location, helping patients identify potential research opportunities that may be relevant to their care.

Personalized Support
Provides a conversational experience tailored to each user’s questions and informational needs.

Accessibility
Simplifies complex medical terminology and offers SMS access for users without reliable internet. Questions can be texted to 318-ChatCRC (318-242-8272).

24/7 Availability
Delivers immediate access to trusted colorectal cancer information whenever it is needed.

Connection to Resources
Connects users with Fight CRC educational resources, support programs, and additional tools designed to help patients throughout their care journey.

Interactive Experience
Allows users to ask questions and receive immediate, personalized responses.

ChatCRC does not provide medical advice and should never be used as a substitute for guidance from a qualified healthcare provider. ChatCRC does not store or retain any personal health information or other personal data uploaded by users.

Recent user feedback continues to demonstrate ChatCRC’s impact, with 100% of surveyed users reporting the tool was “Very easy” or “Easy” to use. Nearly all respondents said they would use ChatCRC again, and 100% said they would recommend it to a friend.

“ChatCRC worked very well, providing accurate and thorough answers to my questions. I would use it again and recommend it to friends.”

– Rich Goldberg, MD

To start using ChatCRC, visit https://chatbot.fightcolorectalcancer.org/.

ChatCRC is supported by: Abbott, Amgen, Bristol Myers Squibb, Daiichi Sankyo, and Pfizer.

The post Fight Colorectal Cancer Expands ChatCRC with Biomarker Report Reader and Clinical Trial Finder appeared first on Fight Colorectal Cancer.

The post Protected: What is the Summer of Action? appeared first on Fight Colorectal Cancer.

Clinical Trials Roundup

Curated by Fight CRC’s Medical Advisory Board & Research Advocacy Training and Support (RATS) team.

This month, we’re spotlighting actively recruiting colorectal cancer clinical trials connected to two key data readouts from the 2026 ESMO Gastrointestinal Cancers Congress (July 1-4, Munich): new liquid biopsy-guided anti-EGFR sequencing data in RAS/BRAF wild-type metastatic CRC, and three-year landmark survival data for botensilimab plus balstilimab in refractory MSS metastatic CRC. These summaries can help patients and caregivers start informed conversations with their care team.

Need help understanding clinical trials or biomarker testing? See our resources.

July 2026 

1. OrigAMI-1 — Amivantamab Alone or With Chemotherapy in Chemorefractory RAS/BRAF Wild-Type Metastatic CRC 

Biomarker Focus: RAS/BRAF wild-type and HER2 non-amplified metastatic CRC; tumor sidedness evaluated 
Phase / Sites: Phase Ib/II / International multicenter, including U.S. sites 
Stage: Advanced or metastatic CRC, two to three prior lines of therapy 
Recruitment Status: Active, ongoing (combination chemotherapy cohorts) 
What it’s studying: OrigAMI-1 is the foundational study evaluating amivantamab, a bispecific antibody targeting both EGFR and MET, alone or combined with mFOLFOX6 or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic CRC after two to three prior lines of therapy. 
Why it matters: Updated results at ASCO GI 2026 showed over 70% of patients in the first-line combination chemotherapy subgroup responded, with most responses lasting beyond 16 months; results that launched two pivotal phase 3 studies now enrolling (OrigAMI-2 and OrigAMI-3, below). 
Patient Tip: If you have RAS/BRAF wild-type CRC and have been through several lines of treatment, ask your care team whether early-phase trials studying newer EGFR-targeting combinations are still open to enrollment.
ClinicalTrials.gov: NCT05379595 

2. OrigAMI-2 — Amivantamab + Chemotherapy vs. Cetuximab + Chemotherapy in First-Line Left-Sided RAS/BRAF Wild-Type Metastatic CRC 

Biomarker Focus: RAS/BRAF wild-type (KRAS, NRAS, and BRAF all wild-type); left-sided primary tumor 
Phase / Sites: Phase III / Global multicenter, including U.S. sites 
Stage: Unresectable or metastatic colorectal cancer, first-line 
Recruitment Status: Recruiting 
What it’s studying: OrigAMI-2 is comparing amivantamab plus chemotherapy (mFOLFOX6 or FOLFIRI) versus cetuximab plus chemotherapy as first-line treatment for patients with left-sided, RAS/BRAF wild-type metastatic CRC. 
Why it matters: Anti-EGFR therapy with chemotherapy is already the standard for this group, but resistance develops in most patients. Data from ESMO GI 2026 showed liquid biopsy can track that resistance; OrigAMI-2 is testing whether targeting both EGFR and MET from the start delays it. 
Patient Tip: If your tumor is RAS/BRAF wild-type and left-sided, ask your care team whether there are first-line trials testing a next-generation EGFR-targeting approach before starting standard treatment. 
ClinicalTrials.gov: NCT06662786

3. OrigAMI-3 — Amivantamab + FOLFIRI vs. Cetuximab or Bevacizumab + FOLFIRI in Second-Line RAS/BRAF Wild-Type Metastatic CRC 

Biomarker Focus: RAS/BRAF wild-type (KRAS, NRAS, and BRAF all wild-type) metastatic CRC 
Phase / Sites: Phase III / Global multicenter, including U.S. sites (Fox Chase Cancer Center, UCLA, and others) 
Stage: Recurrent, unresectable, or metastatic CRC after first-line chemotherapy 
Recruitment Status: Recruiting 
What it’s studying: OrigAMI-3 is evaluating subcutaneous amivantamab plus FOLFIRI versus standard second-line treatment (cetuximab or bevacizumab plus FOLFIRI) in patients with RAS/BRAF wild-type metastatic CRC who progressed on first-line chemotherapy. 
Why it matters: MET amplification is a known mechanism by which CRC develops resistance to anti-EGFR therapy after first-line treatment; amivantamab targets both EGFR and MET, and phase 1b/2 data from ASCO GI 2026 showed promising activity even in patients with prior anti-EGFR exposure. 
Patient Tip: If you have RAS/BRAF wild-type CRC and your cancer progressed on first-line therapy, ask your care team whether a second-line trial targeting both EGFR and MET could be right for you. 
ClinicalTrials.gov: NCT06750094

4. Botensilimab + Balstilimab + Fasting Mimicking Diet + Vitamin C for KRAS-Mutant MSS Metastatic CRC 

Biomarker Focus: KRAS-mutant, microsatellite stable (MSS) metastatic colorectal cancer 
Phase / Sites: Phase Ib / University of Southern California (Los Angeles, CA) 
Stage: Metastatic colorectal cancer after prior fluoropyrimidine, oxaliplatin, and irinotecan 
Recruitment Status: Recruiting 
What it’s studying: This study evaluates botensilimab and balstilimab combined with a fasting mimicking diet (a structured, plant-based, low-calorie eating plan) and high-dose intravenous vitamin C in patients with KRAS-mutant MSS metastatic CRC. 
Why it matters: ESMO GI 2026 featured three-year survival data for botensilimab plus balstilimab in MSS CRC; this trial explores whether adding metabolic strategies can extend that benefit to patients with KRAS mutations, who make up a large share of MSS metastatic CRC cases. 
Patient Tip: If your tumor is MSS and has a KRAS mutation, ask your care team whether trials combining immunotherapy with nutritional or metabolic strategies are available to you. 
ClinicalTrials.gov: NCT06336902

 5. Botensilimab + Balstilimab + SBRT for MSS CRC With Liver Metastases 

Biomarker Focus: Non-MSI-H or mismatch repair proficient (pMMR) colorectal cancer with liver metastases 
Phase / Sites: Pilot study / Massachusetts General Hospital (Boston, MA) 
Stage: Metastatic colorectal cancer with liver metastases 
Recruitment Status: Recruiting 
What it’s studying: This study evaluates botensilimab and balstilimab combined with stereotactic body radiation therapy (SBRT) to liver metastases in patients with MSS or pMMR CRC, asking whether precisely targeted radiation can activate an immune response in a setting where immunotherapy alone has been harder to get to work. 
Why it matters: The three-year ESMO GI 2026 BOT/BAL data came from patients without active liver metastases; liver involvement is associated with lower immunotherapy response rates in MSS CRC, and this trial directly addresses that gap. 
Patient Tip: If your cancer has spread to the liver, ask your care team whether trials combining radiation with newer immunotherapy drugs are available at your treatment center. 
ClinicalTrials.gov: NCT07128355 

June 2026

1. HARMONi-GI3 — Ivonescimab + mFOLFOX6 in First-Line Metastatic Colorectal Cancer

Biomarker Focus: Metastatic colorectal cancer; immunotherapy and VEGF pathway strategy
Phase / Sites: Phase III / Multicenter
Stage: Metastatic colorectal cancer
Recruitment Status: Recruiting
What It’s Studying:
This study compares ivonescimab plus mFOLFOX6 chemotherapy with bevacizumab plus mFOLFOX6 for patients who have not yet received systemic treatment for metastatic CRC.
Why It Matters:
First treatment decisions can feel urgent and overwhelming. This trial is studying whether combining chemotherapy with a treatment that targets both immune response and tumor blood-vessel growth may offer another first-line approach.
Patient Tip:
Ask your care team: “Do I know my MSI/MMR status, and are there any first-line clinical trials that match my diagnosis and treatment goals?”
ClinicalTrials.gov: NCT07228832

2. BAY 3771249 — KRAS G12D-Targeted Therapy for Advanced or Metastatic CRC

Biomarker Focus: KRAS G12D mutation
Phase / Sites: Phase I / Multicenter
Stage: Advanced or metastatic colorectal cancer
Recruitment Status: Recruiting
What It’s Studying:
This study is evaluating BAY 3771249, an investigational treatment being studied alone or with cetuximab for patients with advanced or metastatic CRC that has a KRAS G12D mutation.
Why It Matters:
KRAS G12D has limited targeted treatment options. This trial reflects the growing effort to develop therapies based on the exact KRAS mutation driving a person’s cancer.
Patient Tip:
Ask your care team: “Do I have a KRAS G12D mutation, and are there trials designed specifically for this subtype?”
ClinicalTrials.gov: NCT07535112

3. SGN-CEACAM5C — Antibody-Drug Conjugate Targeting CEACAM5

Biomarker Focus: CEACAM5 expression
Phase / Sites: Phase I / International study with U.S. sites
Stage: Advanced solid tumors, including colorectal cancer cohorts
Recruitment Status: Recruiting
What It’s Studying:
This study is evaluating SGN-CEACAM5C, also known as PF-08046050, in adults with advanced solid tumors, including CRC cohorts. Antibody-drug conjugates are designed to deliver treatment more directly to cancer cells with a specific target.
Why It Matters:
When standard treatments stop working, patients often want to know what other options are being studied. This trial is one example of research exploring more targeted approaches for advanced CRC.
Patient Tip:
Ask your care team: “Has my tumor been tested for markers that could help match me to a targeted therapy or antibody-drug conjugate trial?”
ClinicalTrials.gov: NCT06131840

4. EMPIRE / NSABP FC-13 — Immunotherapy for ctDNA-Positive Minimal Residual Disease

Biomarker Focus: ctDNA-positive minimal residual disease after colorectal cancer treatment
Phase / Sites: Phase II / Multicenter
Stage: Colorectal cancer after definitive surgery and chemotherapy, with ctDNA positivity
Recruitment Status: Recruiting
What It’s Studying:
EMPIRE is studying cemiplimab alone or with other immunotherapy-based treatments for people with CRC who are ctDNA-positive after surgery and chemotherapy. ctDNA is tumor DNA that can sometimes be detected through a blood test.
Why It Matters:
Many patients want to know what ctDNA results may mean for recurrence risk and next steps. This study is asking whether immunotherapy-based treatment can help delay or prevent colorectal cancer from coming back in patients with ctDNA-positive minimal residual disease.
Patient Tip:
If you have completed surgery and chemotherapy, ask your care team: “Is ctDNA testing appropriate for me, and would a positive result change my follow-up plan or clinical trial options?”
ClinicalTrials.gov: NCT07058012

5. KANDLELIT-012 — Calderasib (MK-1084) + Cetuximab + mFOLFOX6 for KRAS G12C-Mutated Colorectal Cancer

Biomarker Focus: KRAS G12C mutation
Phase / Sites: Phase III / Multicenter
Stage: Locally advanced unresectable or metastatic colorectal cancer
Recruitment Status: Recruiting
What It’s Studying:
This study is evaluating calderasib, also known as MK-1084, with cetuximab and mFOLFOX6 chemotherapy compared with mFOLFOX6 with or without bevacizumab in KRAS G12C-mutated CRC.
Why It Matters:
KRAS mutations are common in CRC, but not all KRAS mutations are the same. This trial focuses on KRAS G12C and reflects the movement toward treatments matched to specific tumor biomarkers.
Patient Tip:
If your care team says your tumor has a KRAS mutation, ask: “Which KRAS mutation do I have, and does that specific result make me eligible for any clinical trials?”
ClinicalTrials.gov: NCT06997497

6. Bonus Research Watch: CRDF-004 — Onvansertib + Chemotherapy and Bevacizumab for RAS-Mutated Metastatic Colorectal Cancer

Biomarker Focus: KRAS or NRAS mutation
Phase / Sites: Phase II / U.S. multicenter study
Stage: First-line metastatic colorectal cancer
Recruitment Status: Active, not recruiting
What It’s Studying:
CRDF-004 is studying onvansertib with standard chemotherapy and bevacizumab for adults with metastatic CRC that has a KRAS or NRAS mutation.
Why It Matters:
RAS mutations are common in metastatic CRC, and researchers continue to look for better first-line strategies. This trial is not currently recruiting, but it remains important to watch because ASCO 2026 featured interim results from CRDF-004 in first-line RAS-mutated metastatic CRC.
Patient Tip:
If your tumor has a KRAS or NRAS mutation, ask your care team: “Are there current or upcoming trials for RAS-mutated colorectal cancer that may fit my treatment plan?”
ClinicalTrials.gov: NCT06106308

May 2026

1. NCI ComboMATCH — Combination Therapy Based on Tumor Genetics 

Biomarker Focus: Actionable genetic alterations 
Phase / Sites: Screening trial supporting multiple Phase II treatment sub-studies  / U.S. NCI network 
Stage: Advanced solid tumors, including colorectal cancer when biomarker eligible 
Recruitment Status: Recruiting 
What it’s studying: ComboMATCH assigns patients to treatment combinations based on tumor genetic changes rather than cancer type alone, using a screening platform that matches patients to specific sub-studies. 
Why it matters: This builds on precision medicine by testing whether targeted drug combinations can improve outcomes for patients whose tumors have actionable alterations. 
Patient Tip: If you’ve had genomic testing, ask whether your results include an alteration that could match to a precision medicine trial. 
ClinicalTrials.gov: NCT05564377 
 

2. BASECAMP-1 — Screening Study for Future CEA-Targeted Cell Therapy 

Biomarker Focus: CEA expression, HLA type (including HLA loss of heterozygosity), tumor immune markers 
Phase / Sites: Observational screening study / U.S. sites 
Stage: Solid tumors, including colorectal cancer 
Recruitment Status: Recruiting 
What it’s studying: BASECAMP-1 screens patients for biomarkers that may determine eligibility for future CEA-targeted cell therapy studies. 
Why it matters: This expands biomarker testing beyond tumor mutations to include immune matching and cell therapy eligibility. 
Patient Tip: If you’re interested in cell therapy trials, ask whether HLA typing or CEA testing could be relevant. 
ClinicalTrials.gov: NCT04981119 

3. Onvansertib Combination Trial — KRAS-Mutant Metastatic Colorectal Cancer 

Biomarker Focus: KRAS mutation 
Phase / Sites: Phase II / U.S. and international sites 
Stage: Metastatic colorectal cancer 
Recruitment Status: Active, Not Recruiting 
What it’s studying: This study evaluates onvansertib with standard chemotherapy and bevacizumab in patients with KRAS-mutant metastatic colorectal cancer. 
Why it matters: KRAS mutations are common in CRC, but many KRAS-mutant tumors still lack effective targeted options. This study focuses on a biologically defined CRC group. 
Patient Tip: If your tumor has a KRAS mutation, ask whether the specific KRAS variant and prior treatments affect trial eligibility. 
ClinicalTrials.gov: NCT06106308 
 

4. P-MUC1C-ALLO1 — Allogeneic CAR-T Cell Therapy Targeting MUC1-C 

Biomarker Focus: MUC1-C expression 
Phase / Sites: Phase I / Includes U.S. sites 
Stage: Advanced or metastatic solid tumors, including colorectal cancer 
Recruitment Status: Active, Not Recruiting 
What it’s studying: This study evaluates an allogeneic CAR-T cell therapy targeting MUC1-C, a tumor-associated marker expressed in several epithelial cancers. 
Why it matters: Cell therapy research in CRC is expanding, and biomarker testing may help identify patients whose tumors express targets like MUC1-C. 
Patient Tip: Ask whether your tumor testing includes protein-expression markers, not just DNA mutations. 
ClinicalTrials.gov: NCT05239143 

5. GCC19CART — CAR-T Therapy Targeting GCC in Advanced Gastrointestinal Cancers 

Biomarker Focus: GCC / guanylyl cyclase C expression 
Phase / Sites: Phase I / U.S. sites 
Stage: Metastatic colorectal cancer 
Recruitment Status: Recruiting 
What it’s studying: This trial evaluates CAR-T cells targeting GCC, a marker commonly associated with colorectal cancer cells. 
Why it matters: GCC-targeted cell therapy is a CRC-relevant biomarker strategy and represents a newer research direction for patients with advanced disease. 
Patient Tip: If you are exploring cell therapy options, ask whether your tumor expresses GCC or whether a GCC-targeted study is available. 
ClinicalTrials.gov: NCT05319314 

April 2026

1. JANUS Rectal Cancer Trial — Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer 
Biomarker Focus: Response-adapted treatment and organ preservation strategy 
Phase / Sites: Phase II / U.S. cooperative group, multicenter 
Stage: Stage II-III / locally advanced rectal cancer 
Recruitment Status: Active, not recruiting 
What it’s studying: JANUS is comparing long-course chemoradiation followed by mFOLFIRINOX versus mFOLFOX6 to improve clinical complete response and organ preservation in locally advanced rectal cancer. 
Why it matters: This study is relevant right now because it focuses on treatment intensification and organ-preservation goals in rectal cancer—an area of strong interest for patients and clinicians alike. 
Patient Tip: If you are discussing treatment before rectal cancer surgery, ask whether total neoadjuvant therapy or organ-preservation strategies may be appropriate for you. 
ClinicalTrials.gov: NCT05610163 

2. EA2201 — Immunotherapy in dMMR Stage II/III Rectal Cancer 
Biomarker Focus: Deficient mismatch repair (dMMR) / MSI-H 
Phase / Sites: Phase II / Multicenter U.S. trial 
Stage: Stage II–III locally advanced rectal adenocarcinoma 
Recruitment Status: Active, not recruiting 
What it’s studying: EA2201 is evaluating nivolumab + ipilimumab with short-course radiation in patients with MSI-H/dMMR rectal cancer, with the goal of improving response while potentially reducing the need for more intensive conventional treatment. 
Why it matters: dMMR rectal cancer is one of the clearest examples of biomarker-driven care in CRC. This trial reflects the shift toward tailoring treatment based on tumor biology. 
Patient Tip: If your tumor is dMMR or MSI-H, ask whether immunotherapy-based trials may be available before surgery. 
ClinicalTrials.gov: NCT04751370 

3. COMMIT Study — First-Line Immunotherapy Strategy in Metastatic dMMR/MSI-H Colorectal Cancer 
Biomarker Focus: dMMR / MSI-H 
Phase / Sites: Phase III / national multicenter trial 
Stage: Metastatic colorectal cancer 
Recruitment Status: Active, not recruiting 
What it’s studying: COMMIT is testing atezolizumab-based first-line treatment strategies, including chemotherapy/bevacizumab-containing approaches, in metastatic dMMR CRC. 
Why it matters: Although immunotherapy is already important in dMMR/MSI-H CRC, not all patients have durable benefit. COMMIT is trying to refine the best first-line approach for this population. 
Patient Tip: If you have metastatic dMMR/MSI-H CRC and are starting treatment, ask whether a first-line immunotherapy trial is an option. 
ClinicalTrials.gov: NCT02997228 

4. ERAS-007 Combination Trial in Advanced Gastrointestinal Malignancies, Including Colorectal Cancer 
Biomarker Focus: MAPK pathway / BRAF and RAS pathway signaling 
Phase / Sites: Phase Ib/II / Multicenter, including U.S. sites 
Stage: Advanced gastrointestinal malignancies, including metastatic CRC 
Recruitment Status: Completed 
What it’s studying: This study is evaluating ERAS-007, an ERK inhibitor, in combination regimens designed to interrupt downstream MAPK signaling in GI cancers, including CRC. 
Why it matters: Many CRC tumors are driven by pathway alterations that remain difficult to target directly. ERAS-007 reflects a newer strategy aimed at blocking downstream signaling to improve outcomes. 
Patient Tip: If your cancer has a BRAF or RAS-pathway alteration, ask whether downstream pathway-targeting trials may be appropriate. 
ClinicalTrials.gov: NCT05039177 

5. Nous-209 Vaccine Prevention Study in Lynch Syndrome 
Biomarker Focus: Lynch syndrome / mismatch repair deficiency risk 
Phase / Sites: Phase Ib/II / U.S.-based prevention study 
Stage: High-risk individuals with Lynch syndrome 
Recruitment Status: Active, not recruiting 
What it’s studying: This study is evaluating the Nous-209 vaccine strategy for cancer prevention in Lynch syndrome carriers at elevated risk for colon and other Lynch-associated cancers. 
Why it matters: This is a prevention-focused trial rather than a treatment trial, but it is highly relevant to colorectal cancer because it aims to reduce future cancer risk in a well-defined high-risk population. 
Patient Tip: If you or your family members have Lynch syndrome, ask whether prevention studies or surveillance-focused research may be appropriate. 
ClinicalTrials.gov: NCT05078866 

March 2026

1. ARPA-H ADAPT Oncology Platform – Colorectal Cohort 

Biomarker Focus: Real-time biomarker integration and adaptive trial infrastructure 
Phase / Sites: Early research initiative / United States 
Stage: Colorectal cancer (see eligibility criteria in protocol) 
Recruitment Status: Not yet recruiting 
What it’s studying: This ARPA-H supported initiative is part of the ADAPT oncology platform, designed to modernize how cancer clinical trials are conducted. The platform integrates advanced biomarker monitoring, coordinated data systems, and adaptive treatment strategies to accelerate therapeutic development in CRC and other cancers. 
Why it matters: Rather than testing a single drug, this national investment focuses on transforming the clinical trial system itself — potentially speeding up how promising treatments move from concept to clinic. 
Patient Tip: Even if enrollment hasn’t begun, ask your care team about upcoming federally funded research programs that may open new opportunities. 
ClinicalTrials.gov: NCT07318389

2. Molecularly Guided Therapy Based on Tumor Genetics: NCI-MATCH 

Biomarker Focus: Actionable genetic mutations 
Phase / Sites: Phase 2 / Nationwide (NCI-sponsored) 
Stage: Advanced solid tumors, including colorectal cancer 
Recruitment Status: Active, not recruiting 
What it’s studying: NCI-MATCH assigns treatment based on specific genetic mutations found in a tumor rather than the cancer’s location in the body. Patients with colorectal cancer whose tumors harbor actionable mutations may be matched to targeted therapies designed for those alterations. 
Why it matters: This national precision-medicine trial helped redefine how we think about treatment selection. Instead of a one-size-fits-all approach, MATCH reflects a shift toward therapy guided by tumor biology. 
Patient Tip: If you’ve had comprehensive genomic testing, ask whether your tumor’s mutations may qualify you for a MATCH sub-study. 
ClinicalTrials.gov: NCT02465060

3. COBRA Trial: ctDNA-Guided Predictor in Stage IIA 

Biomarker Focus: Circulating tumor DNA (ctDNA) 
Phase / Sites: Phase 2/3 / U.S. cooperative groups 
Stage: Stage II colon cancer 
Recruitment Status: Active 
What it’s studying: The COBRA study evaluates whether ctDNA testing after surgery can identify patients who truly need chemotherapy and who may safely avoid it. 
Why it matters: This study reflects the growing role of blood-based biomarkers in guiding adjuvant therapy, with the goal of reducing overtreatment while maintaining excellent outcomes. 
Patient Tip: If you have stage II colon cancer, ask whether ctDNA testing is appropriate for you and whether participation in a biomarker-guided trial is an option. 
ClinicalTrials.gov: NCT04068103

4. SWOG S2107: Immunotherapy Strategies in MSS Metastatic CRC 

Biomarker Focus: Microsatellite stable (MSS) and BRAF V600E mutation 
Phase / Sites: Phase 2 / National cooperative group (SWOG) 
Stage: Previously treated metastatic colorectal cancer 
Recruitment Status: Recruiting 
What it’s studying: This study is testing whether adding nivolumab (immunotherapy) to encorafenib + cetuximab improves outcomes in BRAF V600E/MSS metastatic CRC. 
Why it matters: Approximately 85–90% of colorectal cancers are MSS. Expanding immunotherapy strategies for this population remains one of the most urgent research priorities in CRC, and to a population that historically does not benefit from single-agent checkpoint inhibitors. 
Patient Tip: If you’ve been told your tumor is MSS and that immunotherapy alone is unlikely to work, ask whether combination immunotherapy trials are available at your treatment center. 
ClinicalTrials.gov: NCT04963283 

5. CIRCULATE-US (NRG-GI008) — ctDNA-Guided Adjuvant Strategy in Stage II/III 

Biomarker Focus: Circulating tumor DNA (ctDNA) 
Phase / Sites: Phase II/III / North America (NRG Oncology) 
Stage: Stage II and III (resected) colon cancer 
Recruitment Status: Recruiting 
What it’s studying: This randomized study evaluates whether post-surgical ctDNA testing can guide escalation or de-escalation of chemotherapy in patients with stage II or III colon cancer. Patients who test ctDNA-positive may receive intensified therapy, while those who test ctDNA-negative may receive less intensive treatment. 
Why it matters: ctDNA is emerging as a precision tool to detect minimal residual disease and personalize adjuvant therapy decisions. 
Patient Tip: If you’ve had surgery for stage II or III colon cancer, ask whether ctDNA testing or enrollment in a ctDNA-guided trial is appropriate for you. 
ClinicalTrials.gov: NCT05174169 

February 2026

1. BRAFTOVI® + Cetuximab + FOLFIRI — New Triplet Regimen for BRAF V600E mCRC

Biomarker Focus: BRAF V600E mutation
Phase / Sites: Phase 2 / Multinational (Pfizer-sponsored)
Stage: Metastatic (mCRC)
Recruitment Status: Active, not recruiting
What it’s studying: This study evaluates the combination of encorafenib + cetuximab + FOLFIRI in patients with previously treated, BRAF V600E-mutated metastatic CRC.
Findings: Results from ASCO GI 2026 show a significant increase in overall response rates (ORR) and progression-free survival compared to historical controls.
Why it matters: Offers a promising targeted therapy option earlier in the treatment journey for patients with BRAF-mutant CRC.
Patient Tip: If your tumor is BRAF V600E-positive and you’ve been previously treated, ask your care team about this combination.
ClinicalTrials.gov: NCT04607421

2. CIRCULATE-North America (NRG-GI008) — ctDNA-Guided Adjuvant Therapy in Stage II/III CRC

Biomarker Focus: Circulating tumor DNA (ctDNA)
Phase / Sites: Phase II/III / North America (NRG Oncology)
Stage: Stage II and III (resected)
Recruitment Status: Recruiting
What it’s studying: This randomized trial evaluates whether ctDNA testing after surgery can guide the need for adjuvant chemotherapy in patients with stage II or III colon cancer. Patients with detectable ctDNA may receive intensified treatment, while ctDNA-negative patients may avoid unnecessary chemotherapy.
Presented: ASCO GI 2026
Why it matters: ctDNA is emerging as a precision tool for assessing minimal residual disease (MRD). This trial could help patients avoid overtreatment—or identify recurrence risk earlier.
Patient Tip: If you’ve had surgery for stage II or III colon cancer, ask if ctDNA testing might inform your follow-up care plan.
ClinicalTrials.gov: ASCO Abstract: NRG-GI008

3. KEYNOTE-975 Subanalysis — Pembrolizumab in dMMR/MSI-H mCRC

Biomarker Focus: dMMR / MSI-H
Phase / Sites: Phase 3 / Global
Stage: Metastatic
Recruitment Status: Ongoing
What it’s studying: Examining the efficacy of pembrolizumab as a first-line treatment for dMMR/MSI-H metastatic CRC.
Findings: Durable responses reported in previously untreated patients, including those with comorbidities and older age groups.
Why it matters: Validates immunotherapy as a frontline option in dMMR CRC—not just for ideal candidates.
Patient Tip: If your tumor is MSI-H or dMMR, ask if you qualify for first-line immunotherapy.
ClinicalTrials.gov: NCT04003636

4. BEACON-Lite Cohort A — Real-World Evaluation of Triplet Therapy in BRAF CRC

Biomarker Focus: BRAF V600E mutation
Phase / Sites: Phase 2 / Expanded access
Stage: Metastatic
Recruitment Status: Closed to new participants
What it’s studying: A cohort evaluating encorafenib + cetuximab + chemotherapy in patients not eligible for the original BEACON trial.
Findings: Preliminary real-world data shows efficacy in older patients and those with comorbidities.
Why it matters: Supports more inclusive criteria for accessing promising triplet regimens.
Patient Tip: If you were previously excluded from BRAF-targeted trials, ask if real-world data may now support this approach.
ClinicalTrials.gov: NCT02928224

January 2026

1. BREAKWATER Trial — Triplet Therapy Sets New Standard for BRAF V600E mCRC

Biomarker Focus: BRAF V600E mutation
Phase / Sites: Phase 3 / Multi-national
Stage: Stage IV (metastatic)
Recruitment Status: Completed (Phase 3)
What it’s studying: Encorafenib + cetuximab + FOLFIRI vs chemotherapy in first-line mCRC
Findings: PFS nearly doubled (12.8 vs 7.1 months); OS improved to 30.3 vs 15.1 months
Why it matters: A new triplet could replace chemo as the standard for BRAF-mutated mCRC
Patient Tip: If you have BRAF V600E-mutant CRC and are starting first-line treatment, ask whether this triplet regimen is being considered.
ClinicalTrials.gov: N/A

2. ATOMIC Trial — Atezolizumab + Chemo in Stage III dMMR CRC

Biomarker Focus: Mismatch repair deficiency (dMMR / MSI-H)
Phase / Sites: Phase 3 / Multi-center
Stage: Stage III (resected)
Recruitment Status: Completed
What it’s studying: mFOLFOX6 with or without atezolizumab after surgery in stage III colon cancer
Findings: 3-year disease-free survival improved to 86.4% vs 76.6%
Why it matters: May change adjuvant therapy for early-stage dMMR CRC
Patient Tip: If your tumor is MSI-H/dMMR and you’re receiving adjuvant chemo, ask whether immunotherapy was considered or studied in your care setting.
ClinicalTrials.gov: NCT02912559

3. IVX037 + Sintilimab in MSS CRC — RNA Virus Therapy for IO-Resistant Tumors

Biomarker Focus: Microsatellite stable (MSS), KRAS mutations
Phase / Sites: Phase 1 / Single site (expansion)
Stage: Stage IV (refractory)
Recruitment Status: Expansion underway (Phase 1a complete)
What it’s studying: A bio-selected, receptor-targeted oncolytic RNA virus (IVX037) injected into tumors, combined with anti-PD-1 sintilimab
Findings: Disease control in patients with MSS and KRAS G12D CRC; early immune activation observed
Why it matters: One of the first intratumoral viral therapies showing benefit in MSS CRC: a population typically unresponsive to immunotherapy
Patient Tip: If your tumor is MSS and you’ve exhausted chemo options, ask your care team about clinical trials exploring novel immunotherapy combinations or virus-based therapies.
ClinicalTrials.gov: N/A

4. DYNAMIC-III Trial — ctDNA-Guided Escalation in Stage III CRC

Biomarker Focus: Circulating tumor DNA (ctDNA)
Phase / Sites: Phase 2 / Australia
Stage: Stage III (resected)
Recruitment Status: Completed
What it’s studying: Use of post-surgical ctDNA to guide chemotherapy intensity
Findings: Escalation based on ctDNA positivity improved outcomes; negative ctDNA patients avoided unnecessary chemo
Why it matters: Further validates ctDNA as a tool for adjuvant therapy decisions
Patient Tip: If you’ve had surgery for stage III CRC, ask if ctDNA testing could help tailor your chemotherapy plan.
ClinicalTrials.gov: NCT03803553

5. Tumor-Agnostic ADC Use in CRC – Real-World Data on KRAS G12C and HER2+ Subtypes
Biomarker Focus: KRAS G12C, HER2, and ADC-responsive profiles
Phase / Sites: Retrospective / Multiple centers
Stage: Stage IV (refractory)
Recruitment Status: Retrospective analysis of real-world patients (not an interventional trial)
What it’s studying: Outcomes among CRC patients treated with tumor-agnostic antibody-drug conjugates (ADCs) in third-line or later settings
Findings: HER2+ and KRAS G12C patients experienced stable disease or prolonged progression-free survival with investigational ADCs
Why it matters: Highlights the transition of novel ADCs from trials to practice and underscores the importance of biomarker matching in refractory mCRC
Patient Tip: If you’ve already tried standard treatments, ask your provider about biomarker testing for targets like HER2 or KRAS G12C, which may open access to novel ADC-based strategies through expanded access or real-world use.
ClinicalTrials.gov: N/A

The post On Our Radar: July 2026 Clinical Trials Roundup appeared first on Fight Colorectal Cancer.

Cancer Cell. 2026 Jul 9:S1535-6108(26)00296-5. doi: 10.1016/j.ccell.2026.06.009. Online ahead of print.

ABSTRACT

Colorectal cancer (CRC) metastases frequently recur due to minimal residual disease (MRD) and persistent micrometastases after therapy. Here, we performed spatial multimodal profiling using spot-level and high-resolution spatial transcriptomics, multi-regional whole-genome sequencing following laser-capture microdissection, and high-plex protein imaging to map 49 tumors from 19 patients, encompassing paired primary CRC and matched liver (CLiM) and lung (CLuM) metastases. Phylogenetic reconstruction revealed that liver micrometastases (CLiMi) arose from early clonal divergences and harbored a stem-like, quiescent state consistent with metastatic dormancy. Spatially, we uncovered distinct stromal barriers: macrometastases were encapsulated by myofibroblasts, whereas micrometastases were surrounded by immunosuppressive niches characterized by T cell exhaustion and distinct ligand-receptor signaling networks. Notably, we identified a CLiMi-specific six-gene signature associated with MRD status, disease-free survival, and chemotherapy resistance across multiple independent cohorts. These findings elucidate the spatial evolutionary landscape of CRC metastases and provide tissue-based spatially validated biomarkers for surveillance and therapeutic targeting.

PMID:42425074 | DOI:10.1016/j.ccell.2026.06.009

The post Spatial multi-omics landscape of colorectal cancer macro- and micrometastases appeared first on Fight Colorectal Cancer.

Int J Cancer. 2026 Jul 9. doi: 10.1002/ijc.70615. Online ahead of print.

ABSTRACT

Colorectal cancer (CRC) remains a leading cause of cancer-related morbidity and mortality worldwide yet is largely preventable through effective screening and surveillance. While most CRC cases are sporadic, a substantial proportion occur in individuals at increased risk due to hereditary cancer syndromes or family history who require tailored screening strategies different from population-based approaches with respect to age of initiation, surveillance intervals, and modality. This review summarizes current evidence on CRC risk across higher risk groups, including Lynch syndrome, polyposis syndromes, carriers of moderate-penetrance genes, and individuals with a family history of CRC. Efficacy of colonoscopic surveillance and the potential roles of emerging biomarker tests and artificial intelligence-assisted technologies for detection of colorectal neoplasia are discussed. Current CRC surveillance guidelines, quality metrics and adherence in higher risk groups are reviewed. As research in genomics, biomarkers, microbiome, and artificial intelligence evolves, personalized risk-based screening strategies hold promise for optimizing CRC prevention. High-quality, population-specific data will be essential to refine surveillance intensity, improve adherence, and reduce CRC burden in higher risk populations.

PMID:42423119 | DOI:10.1002/ijc.70615

The post Colorectal Cancer Screening in Hereditary and Familial High-Risk Populations: Best Practices and Future Directions appeared first on Fight Colorectal Cancer.

CA Cancer J Clin. 2026 Jul-Aug;76(4):e70090. doi: 10.3322/caac.70090.

ABSTRACT

This article provides updated global cancer statistics for the year 2024 based on the GLOBOCAN estimates of the International Agency for Research on Cancer. The authors describe national cancer incidence and mortality by world region and the Human Development Index and predict the burden in 2050 based on demographic trends. In 2024, an estimated 20.6 million new cancer cases (19.5 million excluding nonmelanoma skin cancer) and 9.8 million deaths (9.7 million excluding nonmelanoma skin cancer) occurred worldwide, equivalent to one in five people developing cancer during their lifetime and one in nine men and one in 13 women dying from the disease. Lung cancer is the most frequently diagnosed cancer, responsible for almost 2.6 million new cases (12.8%), followed by female breast (11.8%), colorectal (9.9%), prostate (7.5%), and stomach (4.7%) cancer. Lung cancer is also the leading cause of cancer death, with an estimated 1.9 million deaths (19.1%), followed by colorectal (9.4%), liver (7.5%), female breast (7.1%), and stomach (6.6%) cancer. Incidence rates vary four- to five-fold across regions, with the highest rates found in Australia/New Zealand (men, 477 per 100,000; women, 396 per 100,000), whereas mortality rates differ two-fold, with elevated rates in Eastern Europe for men (158 per 100,000) and Melanesia for women (108 per 100,000). The incidence burden is predicted to reach 34.4 million by 2050, up 67% from 2024, with the largest proportional increases in lower Human Development Index countries. Although global variation in cancer profiles demands a nuanced approach to cancer control at national and regional levels, primary prevention must be at the forefront, including intensified efforts to reduce tobacco use, prevent infections, lower alcohol consumption and excess body weight, and increase physical activity.

PMID:42417444 | DOI:10.3322/caac.70090

The post Global cancer statistics 2024: GLOBOCAN estimates of incidence and mortality worldwide for 34 cancers in 186 countries appeared first on Fight Colorectal Cancer.

J Med Internet Res. 2026 Jul 3;28:e87037. doi: 10.2196/87037.

ABSTRACT

BACKGROUND: The use of web-based approaches to identify, recruit, enroll, survey, and interview health-related research participants has increased over time, with rapid acceleration since the COVID-19 pandemic. These approaches can make research more accessible to a broader population, but also increase the risk of fraudulent or imposter participants infiltrating research studies. While this threat has been discussed extensively in quantitative survey research, less has been reported in qualitative and mixed methods studies.

OBJECTIVE: This study aims to identify recurring patterns of fraudulent study participation and to offer strategies for identification, remediation, and reporting.

METHODS: Encounters with fraudulent or imposter individuals during recruitment, enrollment, survey distribution, data collection, and focus group sessions in 2 multisite qualitative and mixed methods research studies are presented. Content from both studies was analyzed to identify common themes and develop strategies for prevention and remediation.

RESULTS: Investigators across 2 multisite studies observed several indicators of suspected fraudulent activity, including large response volumes over a short period, highly repetitive email addresses, higher-than-expected proportions of phone numbers with area codes outside the study area, and unusual email/phone responses using atypical language and phrasing. Several imposter or fraudulent individuals disrupted online focus group sessions. To mitigate these issues, both studies implemented remediation strategies, including enhanced screening procedures at baseline, cross-checking of survey responses, and additional identity verification methods prior to participation. Studies took various actions to address these experiences, including notifying the institutional review board, recruitment platforms, and funders.

CONCLUSIONS: This multisite study identified multiple ways that imposter or fraudulent participants can pose a significant and evolving threat to the integrity of qualitative and mixed methods. These types of fraudulent actors can distort data and undermine research credibility. Lessons learned highlight the importance of real-time recruitment and enrollment analysis and the need for transparent reporting. Addressing this issue will require a comprehensive approach to prevent and address fraudulent study participation that includes collaboration with multiple stakeholders and the broader research community to effectively address this issue.

PMID:42398058 | DOI:10.2196/87037

The post Detecting and Preventing Fraudulent Participation in Qualitative Research: Content Analysis of Two Multisite Studies appeared first on Fight Colorectal Cancer.

J Natl Cancer Inst. 2026 Jul 1:djag207. doi: 10.1093/jnci/djag207. Online ahead of print.

ABSTRACT

BACKGROUND: Small bowel adenocarcinoma (SBA) is a rare malignancy with poor prognosis. Its clinical and pathologic characteristics are sparse, and few studies have examined its genetic features within the continuum of the gastrointestinal tract.

METHODS: Patients (n = 243) from six institutions with SBA and available tumor tissue underwent targeted tumor sequencing. A hidden genome classifier (HGC) was developed based on analyses of 286 gastroesophageal (foregut) and 286 colorectal (hindgut) cancers. SBA samples were assigned to foregut (n = 61), hindgut (n = 61) or mixed-type (n = 121) lineages using predefined HGC score thresholds. Overall survival (OS) was calculated from 90 days post resection until date of last follow-up for patients who underwent curative-intent resection.

RESULTS: HGC classified 54% of duodenal and 64% of intestinal-type periampullary tumors as foregut; 56% of jejunal and 68% of ileal tumors were classified as hindgut. Foregut showed amplifications in CDK12, CD3, EGFR, KRAS and cytoband changes at 8p21.1/15q26.3; hindgut harbored APC and KRAS mutations; mixed-type combined features. Median OS was 73 months (95%CI, 53 to 130) after curative-intent resection. The HGC prediction group (hindgut vs mixed-type, HR 2.80, 95%CI, 1.35-5.75) and age (HR 1.03, 95%CI, 1.01-1.05) were associated with decreased survival. Anatomic site was not associated with OS, whereas driver mutations ARID1A, KRAS and TP53 were associated with OS on univariate analysis.

CONCLUSION: SBAs display genomic heterogeneity. The novel HGC stratifies these tumors based on homology to foregut or hindgut alterations and may be superior to anatomic location for characterizing pathology. Additional studies are needed to validate and further explore these findings.

PMID:42384930 | DOI:10.1093/jnci/djag207

The post A novel classification of small bowel adenocarcinoma based on the hidden genome classifier: a multi-institutional study appeared first on Fight Colorectal Cancer.