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CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer
Sponsor: Fudan University
Summary
TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, organ or anal preservation rate, 3-year DFS rate, etc.
Official title: A Prospective Randomized Phase II Trial of CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for Microsatellite Stable Locally Advanced Rectal Cancer (TORCH-iTNT)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
192
Start Date
2024-03-28
Completion Date
2028-12-31
Last Updated
2026-04-03
Healthy Volunteers
No
Interventions
PD-1 inhibitor
PD-1 inhibitor (Toripalimab): 240mg d1 q3w
Capecitabine
Capecitabine: 1000mg/m2 bid d1-14 q3w
Short-course radiotherapy
Short-course radiotherapy: 25Gy/5Fx
Oxaliplatin
Oxaliplatin 130mg/m2 d1 q3w
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China