drugset / Trial / NCT07837362
SCRT Combined With CAPOX and PD-1/CTLA4 Antibody for Early-stage Low Rectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
The study evaluates the combination of immunotherapy of PD-1/ CTLA4 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1/ CTLA4 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.
Timeline
- Start
- 2026-09-01
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Iparomlimab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | — |
| Subject | Tuvonralimab | Monoclonal antibody | 5 mg/kg | — |