Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Multi-center Randomized Control Phase II Trial

This study aims to observe and evaluate the efficacy and safety of moderately hypofractionated radiotherapy combined with chemotherapy and immunotherapy, compared with conventional neoadjuvant chemoradiotherapy, in patients with high-risk locally advanced colorectal cancer.

NCT Number	NCT07527520
Lead Sponsor	Fudan University
Conditions	Rectal Cancer, Moderately Hypofractionated Radiotherapy, Serplulimab, pMMR/MSS
Enrollment	165 participants
Start Date	2026-06
Primary Completion	2028-07 (estimated)
Study Completion	2031-06 (estimated)
Updated on ClinicalTrials.gov	2026-04-14