CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer
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, anal preservation rate, 3-year DFS rate, etc.
- EligibilityCriteria: Inclusion Criteria:  Pathological confirmed adenocarcinoma; Clinical stage T3-4 and/or N+; The distance from anal verge ≤ 12 cm; Without distance metastases; Age 18-70 years old, female and male; KPS ≥ 70; 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 previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc; 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. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult