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

RecruitingPhase 2Ages 18 Years - 70 YearsAllFudan University
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In plain words

What the trial is, and whether it could suit you

TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge โ‰ค12cm) 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria 1. Age 18-70 years old, female and male; 2. Pathological confirmed adenocarcinoma; 3. The distance from anal verge โ‰ค 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 โ‰ค5 cm, cT4, cN2, positive cMRF, positive cEMVI, or positive lateral lymph nodes; 7. KPS โ‰ฅ 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 โ‰ฅ 1.5 ร— 10\^9/L, Hb โ‰ฅ 90 g/L, PLT โ‰ฅ 100 ร— 10\^9/L, ALT/ AST โ‰ค 2.5 ULN, Cr โ‰ค 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.
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What it tests

  • PD-1 inhibitor
  • Capecitabine
  • Short-course radiotherapy
  • Oxaliplatin
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Where

1 site
Fudan University Shanghai Cancer Center
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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