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

NCT06281405 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

  • Locally Advanced Rectal Cancer
  • Neoadjuvant Therapy

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhen Zhang, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2026-06-30
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281405 on ClinicalTrials.gov