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ctDNA-Guided Immunotherapy for dMMR/MSI-H Colon Cancer
Sponsor: Fudan University
Summary
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.
Official title: A Single-Arm Phase II Study of Circulating Tumor DNA-Guided Neoadjuvant Immunotherapy for dMMR/MSI-H Colon Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
23
Start Date
2026-09-14
Completion Date
2030-12-31
Last Updated
2026-09-25
Healthy Volunteers
No
Interventions
PD-1 inhibitor
200 mg intravenously on Day 1 of each 3-week cycle. All participants receive initial monotherapy.
CTLA-4 inhibitor
1 mg/kg intravenously on Day 1 of each 3-week cycle. Administered with the PD-1 inhibitor only to participants with persistent ctDNA positivity after 3-4 cycles of monotherapy.
ctDNA/MRD testing
Peripheral-blood ctDNA testing at baseline and after 3-4 cycles of monotherapy; every 2 cycles during combination therapy, when applicable; and 1 month after surgery.
Curative Surgery
Curative surgery after ctDNA clearance or after no more than 4 cycles of combination treatment.
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China