Actively Recruiting
CAPOX and PD-1 Antibody With or Without Radiotherapy for Microsatellite Stable Locally Advanced Rectal Cancer (TORCH-iTNT) A Prospective Randomized Phase II Trial
Led by Fudan University · Updated on 2026-04-03
192
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with locally advanced rectal cancer (LARC) to compare total neoadjuvant therapy (TNT) approaches. This prospective, randomized phase II trial involves 198 patients with specific stages of rectal cancer who have tumors located close to the anal verge and no distant metastases. The study aims to assess the complete response rate, including both pathological and clinical complete responses, and also tracks safety and organ preservation outcomes over three years. Participants are assigned to one of two groups. Group A receives six cycles of Toripalimab, a PD-1 inhibitor, combined with chemotherapy drugs capecitabine and oxaliplatin (called ToriCAPOX). Group B receives short-course radiotherapy followed by the same six cycles of ToriCAPOX. After TNT, total mesorectal excision (TME) surgery is planned, but a watch and wait approach may be used if a clinical complete response is achieved. During the study, patients will be monitored for treatment response, side effects, and organ preservation rates. Researchers will perform follow-ups for up to three years to evaluate disease-free survival, local recurrence, distant metastasis, overall survival, and surgical complications. The main outcome is the complete response rate measured about one month after surgery or the decision for watch and wait, with safety monitored through adverse effect rates up to three months after therapy.
CONDITIONS
Brief Title
CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years, male or female
- Pathologically confirmed adenocarcinoma of the rectum
- Tumor located within 10 cm from the anal verge
- Microsatellite stable (MSS) or proficient mismatch repair (pMMR) status
- Clinical stage T3-4 and/or node-positive without distant metastases
- At least one high-risk factor: tumor within 5 cm of anus, stage cT4, stage cN2, positive circumferential resection margin, positive extramural vascular invasion, or positive lateral lymph nodes
- Karnofsky Performance Status (KPS) score of 70 or higher
- No prior radiotherapy, chemotherapy, immunotherapy, or other anti-tumor treatment
- Adequate blood and biochemical values: neutrophils ≥ 1.5 x 10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 10^9/L, liver enzymes ≤ 2.5 times upper limit of normal, creatinine ≤ upper limit of normal
- Able to comply with study requirements and signed informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- History of other cancers within the past 5 years
- Severe neurological or mental illnesses such as schizophrenia, dementia, or epilepsy
- Severe cardiac disease, renal dysfunction, or liver dysfunction
- Recent heart attack or stroke within 6 months before enrollment
- Uncontrolled infections requiring systemic treatment
- Active autoimmune diseases, immunodeficiency, organ transplantation history, or use of immunosuppressive drugs
- Known HIV infection, active syphilis, or active pulmonary tuberculosis infection
- Allergy to any component of the study treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles of 3 weeks each)
Participants receive 6 cycles of CAPOX chemotherapy combined with PD-1 antibody, with or without short-course radiotherapy, as part of their treatment for locally advanced rectal cancer.
Regular visits every 3 weeks for treatment administration
Duration - 1 day for surgery with recovery period
Participants undergo total mesorectal excision (TME) surgery after completing neoadjuvant therapy, or enter a watch-and-wait approach if a complete clinical response is achieved.
1 surgical visit and several post-operative visits
Duration - Up to 3 years
Participants are followed for monitoring of treatment response, adverse effects, and survival outcomes up to 3 years after surgery or watch-and-wait decision.
Periodic visits during follow-up period
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Z
Zhen Zhang, MD
Y
Yaqi Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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