TACE Combined With Anti-PD-1 Antibody in Patients With Advanced Hepatocellular Carcinoma

Written informed consent obtained.Age ≥ 18 years at time of study entry. BCLC stage C, and stage B who are not amenable to curative or locoregional therapies or have progressed thereafter. Histologically confirmed diagnosis of hepatocellular carcinoma. At least one measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI. Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale). Subjects with chronic HBV infection must have HBV DNA viral load < 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy. Life expectancy of at least 12 weeks. Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula ) Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.