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Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
Sponsor: Fudan University
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
Conditions
Interventions
LCRT
50Gy/25Fx
SCRT
25Gy/5Fx
CAPOX
1000mg/m2 bid d1-14
PD-1
300mg d1,q3w
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