drugset / Trial / NCT06903858

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

NCT06903858

Phase 2 Recruiting 105 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

The PICC-3 study is a multicentre, single-arm, phase II trial evaluating toripalimab plus celecoxib in patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) locally advanced colorectal cancer. The trial uses a response-adapted treatment strategy, whereby patients with clinical complete response (cCR) after therapy may enter a non-operative management pathway, while patients without cCR proceed to surgery. Response assessment is based on imaging, endoscopy, biopsy evaluation, and ctDNA analysis.

Timeline

Start
2025-06-01
Primary completion
2028-04-01
Completion
2031-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Celecoxib Other / unclassified 200 mg Oral
Subject Toripalimab Monoclonal antibody 3 mg/kg Intravenous

Indications