Evaluating Pirfenidone and PD-1 Inhibitor With or Without Radiotherapy for Advanced Treatment-Resistant pMMRMSS Colorectal Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of combining pirfenidone with a PD-1 monoclonal antibody, with or without hypofractionated radiotherapy, in adults with advanced, treatment-resistant pMMRMSS colorectal cancer. This Phase II trial focuses on patients whose cancer is unresectable and who have not responded to standard treatments or cannot tolerate them. Participants will receive a PD-1 inhibitor intravenously every 3 weeks alongside oral pirfenidone, which will be gradually increased from 200 mg three times daily to a maintenance dose of 600 mg three times daily. One group will also undergo hypofractionated radiotherapy to metastatic sites, delivering 5 to 8 Gy per fraction over 5 consecutive sessions. Treatment continues until disease progression or unacceptable side effects occur. Throughout the study, participants will be closely monitored with blood tests, imaging to evaluate cancer lesions, and assessments of overall health and side effects. Researchers will measure progression-free survival as the main outcome, with additional evaluations of overall survival, response rate, and adverse events. The trial lasts until at least January 2027, with ongoing safety and efficacy assessments during this period.

A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR/MSS Colorectal Cancer