Bevacizumab in Combination With Sintilimab Versus Transcatheter Arterial Chemoembolization for the Treatment of Intermediate Stage Hepatocellular Carcinoma (Beyond Up-To-Seven Criteria)

Who cannot join

• Previously confirmed fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and bile duct carcinoma.
• history of hepatic encephalopathy or a history of liver transplantation. pleural fluid, ascites, and pericardial effusion with clinical symptoms requiring drainage.
• Acute or chronic active hepatitis B or C infection with hepatitis B virus (HBV) DNA > 2000 IU/ml or 10E4 copies/ml; hepatitis C virus (HCV) RNA > 10E3 copies/ml; positive for both hepatitis B surface antigen (HbsAg) and anti-HCV antibodies. Those who were below the above criteria after antiviral therapy could be enrolled.
• had any of the following within the 12 months prior to study entry: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; ongoing: arrhythmia ≥ grade 2 according to NCI-CTCAE criteria, prolonged QTc interval (>450 ms in men , women >470 ms); Uncontrollable hypertension, systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
• Renal failure requiring hemodialysis or peritoneal dialysis; Severe dysfunction of other vital organs; History of malignancy other than hepatocellular carcinoma within 3 years prior to screening, except for malignancies with negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, limited prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; evidence of brain or soft meningeal lesions; hemophilia or bleeding tendencies, who are taking therapeutic doses of anticoagulant therapy such as coumarin derivative drugs; pregnant or lactating females, all female patients of childbearing potential must have a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result; Prior organ transplant history; Known HIV infection; Active Tuberculosis chemotherapy drug allergy; comorbid systemic or other serious co-morbidities that, in the judgment of the investigator, would make the patient unsuitable for participation in this study or substantially interfere with the appropriate assessment of the safety and toxicity of the prescribed protocol.
• Active or history of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, dry syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
• Patients with other serious acute, chronic physical or psychiatric illnesses or abnormal laboratory tests that may increase the risk associated with study participation or that may interfere with the interpretation of study results or that the investigator deems unsuitable for enrollment.
• Patients with any history of significant noncompliance with medical regimens or inability to obtain reliable informed consent.