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

Launched by FUDAN UNIVERSITY · Feb 25, 2024

Keywords

ClinConnect Summary

This clinical trial, called TORCH-iTNT, is looking at new treatment options for patients with locally advanced rectal cancer, which is cancer that has spread into nearby tissues but not to distant parts of the body. The trial will compare two different treatment approaches. One group of patients will receive a combination of a medication called Toripalimab and chemotherapy (CAPOX) for six cycles. The other group will first receive a type of radiation therapy followed by the same chemotherapy. After these treatments, participants will have surgery to remove the cancer, although some patients who show no signs of cancer may have the option to skip surgery and be monitored closely instead.

To be eligible for this trial, participants should be between 18 to 70 years old and have a confirmed diagnosis of a specific type of rectal cancer. Other requirements include having a certain stage of cancer that hasn’t spread to other parts of the body, and being generally healthy enough to handle the treatment. The trial is not currently recruiting participants, but once it begins, those who join can expect to receive close monitoring throughout the treatment process, including regular check-ups to assess how well the treatment is working and any side effects they may experience.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Pathological confirmed adenocarcinoma;
• • 2. Clinical stage T3-4 and/or N+;
• • 3. The distance from anal verge ≤ 12 cm;
• • 4. Without distance metastases;
• • 5. Age 18-70 years old, female and male;
• • 6. KPS ≥ 70;
• • 7. 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;
• • 8. 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 previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc;
• • 4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
• • 5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
• • 6. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
• • 7. Uncontrolled infection which needs systemic therapy;
• • 8. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
• • 9. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection
• • 10. Allergic to any component of the therapy.