drugset / Trial / NCT05732493
Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Serplulimab | Monoclonal antibody | 300 mg | — |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | — |