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Recruiting NCT06281405

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

Phase II Interventional Locally Advanced Rectal Cancer Neoadjuvant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PD-1 inhibitor, Capecitabine, Short-course radiotherapy, Oxaliplatin.
Who it may be relevant to
Registry conditions: Locally Advanced Rectal Cancer, Neoadjuvant Therapy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

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

Primary outcome measures

  • Complete response (CR) rate [Time frame: 1 month after the surgery or the decision of W&W]
Secondary outcome measures (7)
  • Grade 3-4 adverse effects rate [Time frame: From date of randomization until 3 months after the completion neoadjuvant therapy]
  • 3 year organ or anal preservation rate [Time frame: From date of randomization until the resection of rectum or anus, assessed up to 36 months.]
  • 3 year disease free survival rate [Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.]
  • 3 year local recurrence free survival rate [Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.]
  • 3 year distant metastasis free survival rate [Time frame: From date of randomization until the date of first documented distant metastasis, assessed up to 36 months.]
  • 3 year overall survival rate [Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months.]
  • Rate of surgical complications [Time frame: The surgical complications were assessed within 3 months after the surgery.]

Eligibility criteria

Inclusion criteria

  • Age 18-70 years old, female and male;
  • Pathological confirmed adenocarcinoma;
  • The distance from anal verge ≤ 10 cm;
  • MSI/MMR status: MSS/pMMR;
  • Clinical stage T3-4 and/or N+, without distance metastases;
  • At least one of the following factors is present: distance from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, or positive lateral lymph nodes;
  • KPS ≥ 70;
  • No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;
  • Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10\^9/L, ALT/ AST ≤ 2.5 ULN, Cr ≤ 1 ULN;
  • With good compliance and signed the consent form.

Exclusion criteria

  • Pregnancy or breast-feeding women;
  • Known history of other malignancies within 5 years;
  • Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
  • Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
  • Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
  • Uncontrolled infection which needs systemic therapy;
  • Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
  • Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;
  • Allergic to any component of the therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06281405 · FDRT-2023-290-3409

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗