SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC

Exclusion Criteria

• •Other Malignancies: Diagnosis of another malignancy within 5 years prior to the first dose, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ, localized prostate cancer, or papillary thyroid cancer, etc.
• •Allergy: Known or suspected allergy to the study drugs or any of their excipients.
• •Pregnancy and Lactation: Pregnant or lactating women, or women planning to become pregnant during the study or within 6 months after the last dose.
• •Central Nervous System Disease: Known active epilepsy, active central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
• •Significant Cardiovascular Disease: Clinically significant uncontrolled cardiovascular disease.
• •History of Allergic Disease: History of allergic diathesis, asthma, or atopic dermatitis.
• •Pleural Effusion/Ascites: Presence of significant pleural effusion or ascites.
• •Active Autoimmune Disease: Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose (replacement therapy is allowed).
• •Immunosuppressant Use: Use of systemic corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressants within 2 weeks prior to enrollment.
• •Interstitial Lung Disease: History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonia on screening chest CT scan.
• •Transplantation History: History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
• •Active Infection: Positive HIV test result; Active Hepatitis B (HBV DNA ≥10⁴ copies/mL); Active Hepatitis C (HCV RNA ≥10³ copies/mL); Active Tuberculosis.
• •Gastrointestinal Risk: History of bowel obstruction within 28 days prior to the first study dose; High risk of gastrointestinal perforation.
• •Recent Major Surgery: Major surgical procedure within 4 weeks prior to enrollment.
• •Other Exclusionary Conditions: Any other acute or chronic disease, mental disorder, or laboratory abnormality that, in the investigator's judgment, may increase the risk associated with study participation or drug administration, or interfere with the interpretation of study results.