Study of Toripalimab and Celecoxib with Response-Adapted Non-Surgical Treatment for Locally Advanced Colorectal Cancer with Mismatch Repair Deficiency or High Microsatellite Instability Phase 2 Multicenter Trial

What this Trial Is About

This research investigates the combination of toripalimab and celecoxib in patients with mismatch repair-deficient dMMR or microsatellite instability-high MSI-H locally advanced colorectal cancer. It is a multicenter, single-arm, phase II trial focused on a response-adapted strategy where patients showing a complete clinical response after therapy might avoid surgery, aiming to reduce the risks and long-term effects associated with radical surgery. Participants receive toripalimab intravenously every two weeks for a total of 12 doses, and celecoxib orally twice daily for six months. Patients who achieve a complete clinical response based on imaging, endoscopy, biopsy, and ctDNA tests may enter a non-operative management pathway. Those without a complete response are recommended to undergo curative-intent surgery. Throughout the study, participants will undergo evaluations including imaging, endoscopic examinations, biopsy assessments, and ctDNA analysis to monitor their response. Researchers will measure outcomes such as 3-year event-free survival, clinical and pathological complete response rates, and safety over multiple years. The study duration and follow-up extend up to five years to assess long-term outcomes and treatment-related effects.

Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer