A Prospective, Randomized Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 Treating Advanced HCC

Inclusion Criteria

• •1. Sign and date a written informed consent form prior to the implementation of any trial-related procedures.
• •2. Patients with clinically confirmed unresectable or metastatic hepatocellular carcinoma (HCC).
• •3. Male or female, ≥18 years old, ≤75 years old.
• •4. ECOG Performance Status score of 0\~1.
• •5. Expected survival time \>3 months.
• •6. Barcelona Clinic Liver Cancer (BCLC) Stage B or C for unresectable HCC.
• •7. Suitable for Transarterial Chemoembolization (TACE) treatment.
• •8. Child-Pugh score ≤7.
• •9. At least one measurable lesion according to RECIST 1.1 criteria.
• •22. Active tuberculosis (TB), currently on anti-TB treatment or received anti-TB treatment within 1 year prior to first dose.
• •23. Known human immunodeficiency virus (HIV) infection (positive HIV 1/2 antibodies), known syphilis infection.
• •24. Active or poorly controlled severe infection. Severe infection within 4 weeks prior to first dose, including but not limited to hospitalization for infection complications, bacteremia, or severe pneumonia.
• •25. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is allowed. Known history of primary immunodeficiency. Subjects with only positive autoimmune antibodies should be evaluated by the investigator to confirm the absence of autoimmune disease.
• •26. Use of immunosuppressive medication within 4 weeks prior to first dose, excluding intranasal, inhaled, topical corticosteroids, or systemic corticosteroids at physiologic doses (not exceeding 10 mg/day prednisone or equivalent). Temporary use of corticosteroids for conditions like asthma or COPD is allowed.
• •27. Administration of a live attenuated vaccine within 4 weeks prior to first dose or planned during the study.
• •28. Use of traditional Chinese medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin; except for local use to control pleural or ascitic fluid) within 2 weeks prior to first dose.
• •29. Uncontrolled/uncorrectable metabolic disorders, other non-malignant organ/systemic diseases, or cancer-related sequelae that could lead to higher medical risk and/or uncertainty in survival evaluation.
• •30. Diagnosis of other malignancies within 5 years prior to first dose, except for radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ. If diagnosis of other malignancy was more than 5 years prior, pathological/cytological diagnosis of recurrent/metastatic lesions is required.
• •31. Prior treatment with any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA-4 antibody, or other immunotherapy.
• •32. Known allergy to Sintilimab, Bevacizumab, or their excipients, or history of severe hypersensitivity to other monoclonal antibodies.
• •33. Treatment with other investigational agents within 4 weeks prior to first dose.
• •34. Pregnant or breastfeeding female patients.
• •35. Any other acute or chronic disease, psychiatric condition, or abnormal laboratory finding that, in the investigator's judgment, may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and make the patient unsuitable for entry into this study.