Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer
Summary
The study is a prospective, single-center, single-arm, phase II clinical trial. Patients with pelvic recurrent rectal cancer aged from 18 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, will receive 45-50Gy/25Fx irradiation or 30Gy/15Fx reirradiation (history of pelvic radiation). PD-1 inhibitor (Toripalimab) was used throughout the course of induction chemotherapy (before radiation), concurrent chemoradiation and consolidation chemotherapy (after radiation); radical resection was followed by well-experienced surgeons . The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints were R0 resection rate, 3-year progression-free survival, overall survival, pathological tumor regression grade, operation characteristics and incidence of major surgical complications.
Timeline
- Start
- 2025-01-01
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toripalimab | Monoclonal antibody | 240 mg | — |
| Background | Capecitabine | Small molecule | 825 mg/m2 | — |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Background | Irinotecan | Small molecule | 200 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | — |