NCT05877573

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced
• High-Risk
• Rectal Cancer
• MSS

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab 240mg,d1,q3w
RADIATION	short-term radiotherapy	25Gy/5Fx
DRUG	Oxaliplatin	135mg/m2 d1 q3w
DRUG	Capecitabine	1200mg/m2 d1-14 q3w

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-01-01
• Completion: 2026-08-01
• First posted: 2023-05-26
• Last updated: 2023-07-05

Locations

1 site across 1 country: China