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
Fudan University
138 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
50Gy/25Fx
25Gy/5Fx
1000mg/m2 bid d1-14
300mg d1,q3w
200mg, bid
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT07154316