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RECRUITING
NCT07154316
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2025-08-01

Completion Date

2028-12-30

Last Updated

2025-09-04

Healthy Volunteers

No

Interventions

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

Locations (5)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Anyang Tumor Hospital

Anyang, Henan, China

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Yunnan Cancer Hospital

Kunming, China

Fudan University Shanghai Cancer Center

Shanghai, China