Clinical Research Directory
Browse clinical research sites, groups, and studies.
Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced,High-Risk,MSS Rectal Cancer
Sponsor: Nanfang Hospital, Southern Medical University
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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2023-07-01
Completion Date
2026-08-01
Last Updated
2023-07-05
Healthy Volunteers
No
Interventions
Toripalimab
Toripalimab 240mg,d1,q3w
short-term radiotherapy
25Gy/5Fx
Oxaliplatin
135mg/m2 d1 q3w
Capecitabine
1200mg/m2 d1-14 q3w
Locations (1)
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China