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Study identifier: NCT07154316 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Colorectal Cancer  ·  Sponsor: Fudan University

PhasePhase 2
Planned participants138
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Dawei Li  ·  +86-021-64175590  ·  li_dawei@fudan.edu.cn

Always discuss trial participation with your own doctor first.

Locations (5)

Fujian Provincial Cancer HospitalFuzhou, Fujian, ChinaRecruiting
Anyang Tumor HospitalAnyang, Henan, ChinaRecruiting
The First Affiliated Hospital of Shandong First Medical UniversityJinan, Shandong, ChinaRecruiting
Yunnan Cancer HospitalKunming, ChinaRecruiting
Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07154316