"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"

Who cannot join

• 1. Previous treatment with Regorafenib, PD-1, PD-L1, or CTLA-4 inhibitors, or any form of immunotherapy; 2. Treatment with related drugs or medical technology affecting immunity within 6 months prior to the first dose of the study drug (including but not limited to: thymopentin, interferon, tumor vaccines, CAR-T therapy, etc.); 3. Receiving any study drug, radiotherapy, or major surgery within 28 days prior to the first dose of the study drug; 4. Receiving any anti-tumor treatment (chemotherapy, targeted therapy, etc.) within 3 weeks prior to the first dose of the study drug; 5. Presence of symptomatic central nervous system (CNS) metastases or CNS metastases requiring local CNS-directed therapy (such as radiotherapy or surgery). Exceptions include those previously treated and stable for ≥ 2 months and who have stopped systemic treatment for more than 4 weeks prior to the first dose of the study drug; 6. Known allergy or intolerance to any of the study drugs or their components; 7. Pregnant or lactating females; 8. History of other malignant tumors within the past 5 years (excluding carcinoma in situ or basal cell or squamous cell skin cancer; subjects with other malignant tumors who have been cured for at least 5 years are eligible); 9. Symptomatic congestive heart failure (NYHA Class II-IV), symptomatic or uncontrolled arrhythmias; 10. Poorly controlled hypertension, defined as systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite best medical treatment; 11. Unstable angina (angina symptoms at rest), new onset angina (within the past 3 months), or myocardial infarction within 6 months prior to the first dose of the study drug; 12. Major thrombotic or bleeding events within 6 months prior to randomization (including hemoptysis, gastrointestinal bleeding, hematemesis, central nervous system (CNS) bleeding, severe epistaxis or vaginal bleeding, cerebral infarction, transient ischemic attack, or uncontrolled coronary heart disease). Or requiring lifelong oral anticoagulant therapy; 13. With active, known, or suspected autoimmune diseases; 14. Receiving immunosuppressive agents within 4 weeks prior to the first dose of the study drug, excluding topical glucocorticoids or physiological doses of systemic glucocorticoids administered by nasal, inhalation, or other routes (i.e., no more than 10 mg prednisolone per day or equivalent dosage of other glucocorticoids); 15. Diagnosed with immunodeficiency or on chronic systemic steroid therapy (at a dose in excess of 10 mg prednisone equivalent per day) or any other form of immunosuppressive therapy; 16. History of interstitial lung disease; 17. Active tuberculosis requiring anti-tuberculosis treatment or treatment for tuberculosis within 1 year prior to the first dose of the study drug; 18. Acute or chronic active hepatitis B or hepatitis C; 19. Known history of human immunodeficiency virus (HIV) or syphilis infection; 20. Other active or severe infections requiring systemic antibacterial, antifungal, or antiviral treatment within 4 weeks prior to the first dose of the study drug; 21. Unresolved clinical toxicity ≥ Grade 2 (NCI-CTCAE, v5.0) due to prior anti-tumor treatment, excluding alopecia or non-clinically significant laboratory abnormalities; 22. Intestinal obstruction, gastrointestinal perforation, Crohn's disease, ulcerative colitis, abdominal abscess, chronic diarrhea, or fistula disease within 6 months prior to enrollment; 23. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe cirrhosis; 24. Vaccination with live vaccines within 30 days prior to planned initiation of the study drug (seasonal influenza vaccines without live virus are permitted); 25. History of alcohol abuse or drug abuse; 26. Other acute or chronic diseases, psychiatric disorders, or laboratory abnormalities that the investigator believes would make the use of the study drug unfavorable or affect the interpretation of AEs, or, in the investigator's judgment, would result in inadequate compliance during the study period.