Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06281405

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

Led by Fudan University · Updated on 2026-04-03

192

Participants Needed

1

Research Sites

248 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-70 years old, female and male
  • Pathologically confirmed adenocarcinoma
  • Tumor located within 10 cm from the anal verge
  • Microsatellite stable (MSS) or proficient mismatch repair (pMMR) status
  • Clinical stage T3-4 and/or N+, without distant metastases
  • At least one of the following: tumor within 5 cm of anus, clinical T4, clinical N2, positive circumferential resection margin, positive extramural vascular invasion, or positive lateral lymph nodes
  • Karnofsky Performance Status (KPS) score of 70 or higher
  • No prior radiotherapy, chemotherapy, immunotherapy, or other anti-tumor therapy before enrollment
  • Baseline blood and biochemical values within specified limits: neutrophils ≥ 1.5 × 10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 × 10^9/L, ALT/AST ≤ 2.5 times upper limit normal, creatinine ≤ upper limit normal
  • Able to comply with study procedures and signed informed consent form
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of other cancers within the past 5 years
  • Severe neurological or mental illness (such as schizophrenia, dementia, or epilepsy)
  • Severe cardiac disease (including cardiac dysfunction and arrhythmia), kidney dysfunction, or liver dysfunction
  • Acute heart attack or ischemic stroke within 6 months before enrollment
  • Uncontrolled infections requiring systemic treatment
  • Active autoimmune diseases, immunodeficiencies, history of organ transplantation, or use of immunosuppressive drugs
  • Known HIV infection, active syphilis, or active pulmonary tuberculosis
  • Allergy to any component of the treatment regimen

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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Research Team

Z

Zhen Zhang, MD

CONTACT

Y

Yaqi Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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