drugset / Trial / NCT06525428

Standard Systemic Therapy Combined With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

NCT06525428

Phase 2 Recruiting 96 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

TORCH-M is a prospective, single-arm, two-cohort, investigator-initiated phase II trial to investigate the efficacy and safety of standard systemic therapy in combination with high/low-dose radiotherapy plus toripalimab in paitents with microsatellite stable metastatic colorectal cancer (MSS mCRC). Eligible patients will be assigned to two cohorts according to previous treatment: a first-line cohort A and a second-line cohort B. Patients in both arms will first receive one cycle of standard systemic therapy and toripalimab, followed by high/low-dose radiotherapy, and then continue with standard systemic therapy and toripalimab.The survival benefits, response rates, and adverse effects will be analyzed.

Timeline

Start
2024-04-01
Primary completion
2026-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Toripalimab Monoclonal antibody 240 mg
Background Bevacizumab Monoclonal antibody
Background Cetuximab Monoclonal antibody
Background Irinotecan Small molecule
Background Raltitrexed Small molecule

Indications