Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
Status:
RECRUITING
Trial end date:
2028-12-30
Target enrollment:
Participant gender:
Summary
This randomized phase II trial evaluates the efficacy of long-course chemoradiotherapy (50Gy/25Fx + capecitabine) versus short-course radiotherapy (25Gy/5Fx) combined with CAPOXCapecitabine and Oxaliplatin, PD-1 inhibitor (serplulimab), and COX-2 inhibitor (celecoxib) in MSSMicroSatellite 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.
Phase:
PHASE2
Details
Lead Sponsor:
Fudan University
Collaborators:
Anyang Tumor Hospital Fujian Cancer Hospital Shandong First Medical University Yunnan Cancer Hospital