FIRMmFOLFOX6 and PD1 Antibody for Locally Advanced Rectal Cancer

Study start date: November 1, 2024

Inclusion Criteria: 1. Advanced (cT3-4NxM0 or cTxN+M0) rectal cancer with the lower tumor margin within 15 cm of the anal verge 2. Histopathology confirmed adenocarcinoma with an pMMR/MSS genetic profile. 3. Absence of bowel obstruction, or bowel obstruction relieved by proximal colostomy. 4. Age: 18-75 5. ECOG: 0-1 6. No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy received. 7. Female participants must be non-lactating, with a negative pregnancy test result. Exclusion Criteria: 1. Patients with distant metastasis 2. History of receiving chemotherapy, radiotherapy, targeted therapy, or immunotherapy. 3. Active autoimmune disease requiring systemic treatment within the 2 years prior to enrollment. 4. History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin. 5. History of HIV infection, or active chronic hepatitis B or C with high viral DNA copy numbers. 6. Patients with active tuberculosis currently receiving anti-tuberculosis treatment or treated with anti-tuberculosis therapy within the past year prior to screening. 7. Known or suspected allergy to the study drug or any study-related medications administered. 8. Presence of severe cardiovascular or cerebrovascular disease. 9. Within 14 days prior to the first dose, presence of a severe active or uncontrolled infection requiring systemic therapy, or unexplained fever \>38.5°C. 10. Receiving systemic corticosteroid treatment or other immunosuppressive agents within 14 days prior to the first dose, or immunostimulants within 4 weeks. 11. History of confirmed neurological or psychiatric disorders, including epilepsy or dementia. 12. The participant may be unable to complete the study due to other reasons, or the investigator considers them unsuitable for inclusion. 13. Refusal to sign the informed consent form.