A Single Center Study of Donafenib Combined With PD-1 + TACE in the First-line Treatment of aHCC

Inclusion Criteria: 1. Patients voluntarily enter the study and sign informed consent form (ICF); 2. Age ≥ 18 years and ≤ 75 years, and there is no limit on the gender; 3. Clinically or histologically diagnosed as unresectable HCC; 4. There is at least one measurable lesions that meet the mRECIST standard; 5. Child-pugh classification A or B (score≤7); 6. ECOG : 0 \~ 1 ; 7. The number of intrahepatic tumors ≤ 10 and the maximum tumor diameter ≤ 10cm; 8. Previous TACE treatment ≤ 1 time; 9. Life expectancy ≥ 3 months; 10. For patients with HBV infection, if HBV-DNA is≥10\^4copies/ml within 14 days before enrollment, they should take antiviral treatment first, reduce 1 log or reduce to \<10\^4copies/ml before entering the study, and continue antiviral treatment and monitor liver function and serum HBV-DNA levels; 11. Baseline blood routine and biochemical indexes meet the following criteria within 14 days before treatment: Blood routine examination criteria must be met: (no blood transfusion within 14 days) 1. HB≥90g/L； 2. ANC≥1.5×10\^9/L； 3. PLT≥70×10\^9/L. Biochemical tests are subject to the following criteria: 1. BIL \<1.25xULN ； 2. ALT and AST\<5xULN； 3. Serum creatinine. Less than 1.5 times the upper limit of normal value, Endogenous creatinine clearance\>50ml/min ( Cockcroft-Gault formula)； 4. Albumin≥28g/L； 5. Electrolytes (phosphorus, calcium, magnesium, potassium) ≥ LLN; 6. Urine protein \<2+ or 24-hour urine protein quantitative detection ≤1.0 g/L. Blood coagulation indexes are subject to the following criteria: 1. Prothrombin time (PT) and international normalized ratio (INR) ≤1.5 × ULN; 2. Activated partial thromboplastin time（APTT）≤1.5 × ULN. 12. The serum pregnancy test results of female patients with fertility (referring to premenopausal or non surgical sterilization) must be negative within 14 days before enrollment. Exclusion Criteria: 1. Pathologically confirmed hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC) mixed or fibrolamellar hepatocellular carcinoma; 2. The presence of a tumor thrombus in the main portal vein, biliary tract tumor thrombus, inferior vena cava tumor thrombus, or extrahepatic metastasis; 3. Hepatocellular carcinoma recurrence within 2 years after radical resection or ablation; 4. History of malignancy other than HCC within 5 years; 5. Esophageal and/or gastric varices bleeding within 4 weeks prior to initiation of study treatment; 6. Presence of uncontrolled hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion, or pericardial effusion; 7. Patients who received liver transplant surgery, prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or palliative local treatment ≥2 times for HCC； 8. History of organ and cell transplantation； 9. TACE contraindications identified by the investigator; 10. Active severe infection; 11. Autoimmune disease or immune deficiency; 12. Severe organ (heart, kidney) dysfunction; 13. Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures; 14. Unable to follow the research protocol for treatment or scheduled follow-up; Any other researcher who thinks they cannot be included.