NCT07154316

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

A Randomized Phase II Study of Long-term Chemoradiotherapy or Short-term Radiotherapy Combined With CAPOX, PD-1 Monoclonal Antibody and COX-2 Inhibitors in MSS Type Locally Advanced Rectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
RADIATION	LCRT	50Gy/25Fx
RADIATION	SCRT	25Gy/5Fx
DRUG	CAPOX	1000mg/m2 bid d1-14
DRUG	PD-1	300mg d1，q3w
DRUG	Celecoxib	200mg, bid

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-08-01
• Completion: 2028-12-30
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

5 sites across 1 country: China