Modified Short-Course Radiotherapy Combined With Tislelizumab and CAPOX for pMMR/MSS Rectal Cancer

Korábbi kezelés

• 1. Prior use of PD-1, PD-L1 or other immune checkpoint inhibitors.
• 2. Prior receipt of any anti-tumor therapy for colorectal cancer, including radiotherapy, chemotherapy, or tumor resection.
• 5. Participation in another anti-tumor investigational drug clinical trial within 4 weeks prior to enrollment.
• 7. Confirmed immunodeficiency disease or active autoimmune disease, including but not limited to systemic lupus erythematosus, inflammatory bowel disease, myasthenia gravis, autoimmune hepatitis, rheumatoid arthritis, multiple sclerosis, glomerulonephritis, vasculitis, etc.; use of other immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 4 weeks prior to enrollment.
• 11. Severe infection (CTCAE grade >2) within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active pulmonary inflammation indicated on baseline chest imaging; active tuberculosis infection identified by medical history or CT scan, history of active tuberculosis within 1 year before enrollment, or history of active tuberculosis >1 year previously without adequate treatment.

Más betegség

• 6. History of hypersensitivity to any components of monoclonal antibodies, tislelizumab, capecitabine, or oxaliplatin.
• 8. Known human immunodeficiency virus (HIV) infection; known clinically significant liver disease, including viral hepatitis [active HBV infection (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL), hepatitis C (positive anti-HCV antibody with HCV RNA above the assay lower limit of detection)].
• 10. Uncontrolled cardiac clinical signs or diseases, including but not limited to: a) NYHA class II or higher heart failure; b) unstable angina; c) myocardial infarction within the past 1 year; d) clinically significant supra-ventricular or ventricular arrhythmia that is untreated or poorly controlled after clinical intervention.
• 12. Diagnosis of another malignancy within 5 years before the first dose of study drug, except for malignancies with low risk of metastasis or death (5-year survival rate >90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
• 14. Vulnerable populations other than the elderly or illiterate subjects, including patients with psychiatric disorders, cognitive impairment, critically ill patients, etc.
• 15. Other conditions that, in the investigator's judgment, may force premature termination of study participation.

Laborértékek

• 9. Diseases associated with high bleeding risk such as gastrointestinal hemorrhage, bleeding diathesis, or thromboembolic diseases requiring long-term oral anticoagulants or anti-platelet agents.

Egyéb

• 3. Microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).
• 4. Presence of peritoneal metastasis or metastasis to other distant organs.
• 13. Pregnant or lactating women.

• 1. Participants aged 18 years or older, regardless of gender.
• 2. Tumor located in the rectum, ≤10 cm from the anal verge.
• 3. Histologically confirmed adenocarcinoma, with pMMR by immunohistochemistry or MSS by genetic testing.
• 4. Clinical stage cT3-4N0/+M0.
• 5. ECOG PS 0-1.
• 6. Adequate function of major organs and bone marrow.
• 7. No contraindications to surgery.
• 8. Good compliance and willingness to complete subsequent follow-up.
• 9. Voluntary participation in this study and signed informed consent form.