NCT04518280

Short-course Radiotherapy Based TNT Combined With PD-1 Inhibitor for Locally Advanced Rectal Cancer

A Prospective Phase II Trial of Short-course Radiotherapy Based Total Neoadjuvant Therapy Combined With PD-1 Inhibitor for Locally Advanced Rectal Cancer (TORCH）

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

TORCH is a prospective, multicentre, randomized phase II trial. 130 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. Group A receives SCRT (25Gy/5Fx) followed by 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives 2 cycles of ToriCAPOX followed by SCRT and 4 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, 3-year DFS rate, etc.

Conditions

• Locally Advanced Rectal Cancer

Interventions

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

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-09-01
• Completion: 2025-01-01
• First posted: 2020-08-19
• Last updated: 2025-01-17

Locations

3 sites across 1 country: China