Clinical Study on the Safety and Relationship of Sintilimab Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

This study is designed as a single-center, phase II exploratory clinical trial to evaluate the pathological response rate and safety of sintilimab (PD-1 inhibitor) combined with XELOX regimen (oxaliplatin + capecitabine) for neoadjuvant treatment of LARC. The study focuses on the pMMR/MSS patient population and attempts to provide a new treatment option for patients who cannot tolerate radiotherapy or need to preserve organ function.

NCT Number	NCT07127497
Lead Sponsor	The First Affiliated Hospital of Anhui Medical University
Conditions	Pathological Complete Response, Rectal Cancer, Neoadjuvant Chemoimmunotherapy
Enrollment	50 participants
Start Date	2022-06-01
Primary Completion	2026-10-01 (estimated)
Study Completion	2028-10-01 (estimated)
Updated on ClinicalTrials.gov	2025-11-21