drugset / Trial / NCT07154316
Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
Phase 2
Recruiting
138 enrolled
Fudan University
Anyang Tumor Hospital · collabFujian Cancer Hospital · collabShandong First Medical University · collabYunnan Cancer Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized phase II trial evaluates the efficacy of long-course chemoradiotherapy (50Gy/25Fx + capecitabine) versus short-course radiotherapy (25Gy/5Fx) combined with CAPOX（Capecitabine and Oxaliplatin）, PD-1 inhibitor (serplulimab), and COX-2 inhibitor (celecoxib) in MSS（MicroSatellite Stable） locally advanced rectal cancer, with primary endpoint of complete response rate (pCR+cCR)（Complete Remission） and secondary endpoints including anal preservation rate and 3-year survival outcomes, aiming to elucidate the immunomodulatory effects of triple therapy on tumor microenvironment.
Timeline
- Start
- 2025-08-01
- Primary completion
- 2028-08-01
- Completion
- 2028-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Background | Celecoxib | Other / unclassified | 200 mg | — |
| Background | Oxaliplatin | Small molecule | — | — |
| Background | Serplulimab | Monoclonal antibody | 300 mg | — |