CAPOX plus PD-1 antibody (toripalimab) with or without short-course radiotherapy for MSS locally advanced rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TORCH-iTNT is a randomized, phase II trial enrolling about 198 patients with locally advanced, MSS/pMMR rectal adenocarcinoma. Participants are assigned 1:1 to receive six cycles of toripalimab plus CAPOX chemotherapy (ToriCAPOX) with or without preceding short-course radiotherapy (25 Gy in 5 fractions). After total neoadjuvant therapy (TNT), patients proceed to total mesorectal excision (TME) or may enter a watch-and-wait pathway if they achieve a clinical complete response (cCR). The primary endpoint is the overall complete response rate (pathological pCR plus cCR), and secondary endpoints include high-grade acute adverse events, organ/anal preservation rate, and 3-year disease-free survival.

Why it matters

Who can join: the full rules

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 from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, or positive lateral lymph nodes;
7. KPS ≥ 70;
8. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;
9. 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;
10. With good compliance and signed the consent form.

Exclusion Criteria

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

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Zhen Zhang, MD — Fudan University
• Study coordinator: Zhen Zhang, MD
• Email: zhen_zhang@fudan.edu.cn
• Phone: 18801735029

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.