Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial.

Who can take part

• Subjects must volunteer to participate in the study, signed informed consent, and were able to comply with the program requirements of visits and related procedures
• Age and gender: >18 years old and≤75 years old, both men and women
• All subjects must have Hepatocellular Carcinoma confirmed by pathological or clinical diagnosis
• Subjects are not suitable for radical resection or radical ablative therapy
• BCLC B based on Barcelona Clinic Liver Cancer staging system, and the lesions in the liver exceed up to 7 criteria, the number of tumors + the maximum diameter of tumors > 7
• Patients with viable and measurable target lesion per mRECIST
• Patients who are expected to live more than 3 months
• ECOG PS 0-1
• Child-Pugh class A
• Patients with laboratory values that meet the following criteria:; Hemoglobin≥90 g/L; Neutrophile granulocytes≥1.5×109/L; Platelet count≥75×109/L; Albumin≥30 g/L; Total serum bilirubin ≤ 2 times upper limits of normal; AST and ALT ≤ 5 times upper limits of normal; Serum creatinine ≤ 1.5 times upper limits of normal; Alkaline phosphatase ≤ 5 times upper limits of normal; Prothrombin time or international normalized ratio ≤ 1.5 times upper limits of normal, activated partial thromboplastin time (APTT) ≤ 1.5×ULN

Who cannot take part

• Clinically significant cardiovascular disease, including, but not limited to, acute myocardial infarction, severe/unstable angina or prior coronary artery bypass surgery, congestive heart failure (NYHA >2), poorly controlled arrhythmias or arrhythmias requiring pacemaker therapy, hypertension not controlled by medication (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) within the past 6 months
• History of malignant tumor, excluding the following cases:; Malignant tumor that was curatively treated more than 5 years prior to study entry and has not recurred since then; Successful radical resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, preinvasive cervix carcinoma, and other preinvasive cancers
• Preexisting or history of hepatic encephalopathy, hepatorenal syndrome or liver transplantation
• History of surgical excision or ablation within 4 weeks of the start of treatment
• History of hepatic arterial infusion, more than twice TACE therapy, or history of TACE within 6 months of the start of treatment
• History of systemic therapy, including but not limited to chemotherapy, targeted therapy, immunotherapy
• History of thrombosis and/or embolism within 6 months of the start of treatment
• Clinically severe gastrointestinal bleeding within 6 months of the start of treatment or any life-threatening bleeding events within 3 months of the start of treatment
• Severe infections that are active or clinically poorly controlled
• If accompanied by acute or chronic active hepatitis B, unless taking antiviral drugs
• Other significant clinical and laboratory abnormalities, such as uncontrolled diabetes, chronic kidney disease, grade II or above peripheral neuropathy (CTCAE V5.0), and thyroid dysfunction, that may affect the safety evaluation
• Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma confirmed by histology or cytology
• Diffuse tumor lesion
• The lesions load in the liver exceeds 20, the number of tumors + the maximum diameter of tumors > 20
• Vascular invasion or extrahepatic metastasis
• Clinically uncontrolled ascites or pleural effusion
• Female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant, and fertile female or male patient who is unwilling or unable to use effective contraception
• Multiple branches of hepatic artery with severe variation
• Any other subjects that the investigator considers ineligible