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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm Phase II trial evaluating whether longitudinal ctDNA monitoring can steer treatment decisions in patients with dMMR/MSI-H colon cancer. Participants receive neoadjuvant PD-1 inhibitor therapy, with ctDNA assessed after 3–4 cycles; clearance leads to curative surgery, while persistent ctDNA prompts escalation to combined PD-1 and CTLA-4 inhibition, with reassessment every 2 cycles during combination therapy. All patients undergo curative surgery after ctDNA clearance or after up to four cycles of combination therapy, followed by postoperative ctDNA/MRD testing. The study will measure pathological response, survival outcomes, ctDNA concordance with pathology and imaging, and safety. Interventions include PD-1 inhibitor, CTLA-4 inhibitor, ctDNA/MRD testing, and curative surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent obtained before any study-related procedures.
* Age 18 to 75 years, inclusive.
* Histologically confirmed colon adenocarcinoma, mucinous adenocarcinoma, or signet-ring cell carcinoma, with the tumor located at least 15 cm from the anal verge.
* dMMR/MSI-H status confirmed by immunohistochemistry, polymerase chain reaction, or next-generation sequencing.
* Eastern Cooperative Oncology Group performance status of 0 or 1 and an expected survival of at least 3 months.
* Adequate hematologic, hepatic, renal, coagulation, thyroid, and cardiac function, as defined in the protocol.
* Negative pregnancy test for women of childbearing potential; agreement to use highly effective contraception, when applicable.

Exclusion Criteria:

* Prior treatment with a PD-1 inhibitor, CTLA-4 inhibitor, or other immunotherapy.
* Symptomatic or high-risk bowel obstruction, bleeding, perforation, pneumonitis, or other conditions that may compromise safe study participation.
* Another malignancy diagnosed within 5 years before the first study treatment, except for specified definitively treated low-risk malignancies.
* Current participation in another interventional clinical study, or receipt of another investigational drug or investigational device within 4 weeks before the first study treatment.
* Active autoimmune disease requiring systemic treatment within 2 years before the first study treatment, or recent systemic corticosteroid or other immunosuppressive therapy.
* Uncontrolled pleural effusion or ascites, prior allogeneic organ transplantation (except corneal transplantation), or allogeneic hematopoietic stem cell transplantation.
* Known hypersensitivity to any study drug component.
* Toxicities or complications from prior treatment not recovered to Grade 1 or baseline, except for specified conditions.
* HIV infection, untreated active hepatitis B infection, or active hepatitis C infection.
* Receipt of a live vaccine within 30 days before the first study treatment.
* Pregnancy or breastfeeding.
* Any serious or uncontrolled systemic disease, active infection, clinically significant laboratory abnormality, or other condition that may interfere with study participation or place the participant at unacceptable risk, as judged by the investigator.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Junjie Peng, MD, PhD
• Email: pengjj@shca.org.cn
• Phone: 86-18017317122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.