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RECRUITING
NCT06281405
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China