drugset / Trial / NCT05732493

Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)

NCT05732493

Phase 2 Unknown 120 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

The study evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. In treatment group, a total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the surgery. In observerment group: a total of 60 patients will receive 4 cycles of CAPOX chemotherapy, then receive the surgery. The rate of pathologic complete response (pCR), long-term prognosis and adverse effects will be analyzed.

Timeline

Start
2023-03-01
Primary completion
2023-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Serplulimab Monoclonal antibody 300 mg
Background Capecitabine Small molecule 1000 mg/m2
Background Oxaliplatin Small molecule 130 mg/m2

Indications