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OncoMatch/Clinical Trials/NCT07841236

ctDNA-Guided Immunotherapy for dMMR/MSI-H Colon Cancer

Official title: A Single-Arm Phase II Study of Circulating Tumor DNA-Guided Neoadjuvant Immunotherapy for dMMR/MSI-H Colon Cancer

Is NCT07841236 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including PD-1 inhibitor and CTLA-4 inhibitor for colon cancer.

Phase 2RecruitingFudan UniversityNCT07841236Data as of Oct 2026Location: China

Treatment: PD-1 inhibitor · CTLA-4 inhibitor — This prospective, multicenter, single-arm phase II interventional study evaluates whether longitudinal circulating tumor DNA (ctDNA) monitoring can guide neoadjuvant immunotherapy and surgical decision-making in dMMR/MSI-H colon cancer. Participants with ctDNA clearance proceed to curative surgery, whereas those with persistent ctDNA positivity escalate to combined PD-1 and CTLA-4 inhibitor therapy.

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Extracted eligibility criteria

Treatments studied

Other

PD-1 inhibitorCTLA-4 inhibitor

Cancer type

Colorectal Cancer

Biomarker criteria

Required: MLH1 loss

Required: MSH2 loss

Required: MSH6 loss

Required: PMS2 loss

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

Cannot have received: anti-PD-1 therapy

Prior treatment with a PD-1 inhibitor

Cannot have received: anti-CTLA-4 therapy

Prior treatment with a CTLA-4 inhibitor

Cannot have received: immunotherapy

Prior treatment with ... other immunotherapy

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

Adequate hematologic, hepatic, renal, coagulation, thyroid, and cardiac function, as defined in the protocol.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07841236 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anti-PD-1 therapy, anti-CTLA-4 therapy, immunotherapy disqualifies patients from enrollment.

Does this trial require MLH1?

Yes, MLH1 loss is a required biomarker for enrollment.

Does this trial require MSH2?

Yes, MSH2 loss is a required biomarker for enrollment.

Does this trial require MSH6?

Yes, MSH6 loss is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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