NCT06281405

CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Rectal Cancer
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor	PD-1 inhibitor (Toripalimab): 240mg d1 q3w
DRUG	Capecitabine	Capecitabine: 1000mg/m2 bid d1-14 q3w
RADIATION	Short-course radiotherapy	Short-course radiotherapy: 25Gy/5Fx
DRUG	Oxaliplatin	Oxaliplatin 130mg/m2 d1 q3w

Timeline

• Start date: 2024-03-28
• Primary completion: 2026-06-30
• Completion: 2028-12-31
• First posted: 2024-02-28
• Last updated: 2026-04-03

Locations

1 site across 1 country: China