Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer

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.

NCT Number	NCT07154316
Lead Sponsor	Fudan University Collaborators: Anyang Tumor Hospital, Fujian Cancer Hospital, Shandong First Medical University, Yunnan Cancer Hospital
Conditions	Colorectal Cancer
Enrollment	138 participants
Start Date	2025-08-01
Primary Completion	2028-08-01 (estimated)
Study Completion	2028-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-04