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RECRUITING
NCT07841236
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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

DRUG

PD-1 inhibitor

200 mg intravenously on Day 1 of each 3-week cycle. All participants receive initial monotherapy.

DRUG

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.

DIAGNOSTIC_TEST

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.

PROCEDURE

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