Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer

This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.

NCT Number	NCT05877573
Lead Sponsor	Nanfang Hospital, Southern Medical University Collaborators: Shanghai Junshi Bioscience Co., Ltd.
Conditions	Locally Advanced, High-Risk, Rectal Cancer, MSS
Enrollment	53 participants
Start Date	2023-07-01
Primary Completion	2025-01-01 (estimated)
Study Completion	2026-08-01 (estimated)
Updated on ClinicalTrials.gov	2023-07-05