Overview

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

Status:
Not yet recruiting

Trial end date:
2026-08-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

N/A

Details

Lead Sponsor:

Nanfang Hospital of Southern Medical University

Collaborator:

Shanghai Junshi Bioscience Co., Ltd.

Treatments:

Capecitabine
Oxaliplatin