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Recruiting Phase 2

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

NCT06281405 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2024-03-28
Last updated
2026-04-03

Condition(s) studied

Locally Advanced Rectal CancerNeoadjuvant Therapy

Investigational drug(s) / intervention(s)

PD-1 inhibitor →Capecitabine →Short-course radiotherapyOxaliplatin →

PD-1 inhibitor: PD-1 inhibitor (Toripalimab): 240mg d1 q3w

Capecitabine: Capecitabine: 1000mg/m2 bid d1-14 q3w

Short-course radiotherapy: Short-course radiotherapy: 25Gy/5Fx

Oxaliplatin: Oxaliplatin 130mg/m2 d1 q3w

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Complete response (CR) rate — 1 month after the surgery or the decision of W&W
    Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06281405 on ClinicalTrials.gov ↗ ← All trials in China