NCT07841236RecruitingPhase 2
ctDNA-Guided Immunotherapy for dMMR/MSI-H Colon Cancer
A Single-Arm Phase II Study of Circulating Tumor DNA-Guided Neoadjuvant Immunotherapy for dMMR/MSI-H Colon Cancer
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- First submitted
- 12 Sept 2026
- Start date
- 14 Sept 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT07841236
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 23
- From 14 Sept 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with a PD-1 inhibitor, CTLA-4 inhibitor, or other immunotherapy.
- Current participation in another interventional clinical study, or receipt of another investigational drug or investigational device within 4 weeks before the first study treatment.
- Uncontrolled pleural effusion or ascites, prior allogeneic organ transplantation (except corneal transplantation), or allogeneic hematopoietic stem cell transplantation.
- Toxicities or complications from prior treatment not recovered to Grade 1 or baseline, except for specified conditions.
- Receipt of a live vaccine within 30 days before the first study treatment.
Other illness
- 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.
- Active autoimmune disease requiring systemic treatment within 2 years before the first study treatment, or recent systemic corticosteroid or other immunosuppressive therapy.
- Known hypersensitivity to any study drug component.
- HIV infection, untreated active hepatitis B infection, or active hepatitis C infection.
Lab values
- 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.
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.