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Study identifier: NCT06281405 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Locally Advanced Rectal Cancer · Neoadjuvant Therapy  ·  Sponsor: Fudan University

PhasePhase 2
Planned participants192
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Zhen Zhang, MD  ·  18801735029  ·  zhen_zhang@fudan.edu.cn

Yaqi Wang, MD  ·  18121299593  ·  10301010093@fudan.edu.cn

Always discuss trial participation with your own doctor first.

Locations (1)

Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06281405