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

Recruiting Phase 2 Interventional Study
Locally Advanced Rectal Cancer Neoadjuvant Therapy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
192 (estimated)
Sponsor
Fudan University · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria 1. Age 18-70 years old, female and male; 2. Pathological confirmed adenocarcinoma; 3. The distance from anal verge ≤ 10 cm; 4. MSI/MMR status: MSS/pMMR; 5. Clinical stage T3-4 and/or N+, without distance metastases; 6. At least one of the following factors is present: distance fr…
Contacts

Zhen Zhang, MD

18801735029

zhen_zhang@fudan.edu.cn

CONTACT

Yaqi Wang, MD

18121299593

10301010093@fudan.edu.cn

CONTACT