Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer

Inclusion Criteria: * Signed informed consent prior to any study-related evaluation * Male or female patients over 18 years of age * Unresectable HCC confirmed by histology or by non-invasive AASLD criteria * Measurable disease defined as at least one uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1 * Child Pugh score ≤ 7 points * Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤ 1 * Life expectancy of 12 weeks or more * Eligible to receive standard-of-care sorafenib * Platelet count of \> 50 x 10⁹/L or \> 50% prothrombin activity * Hemoglobin ≥ 8.5 g/dL * Bilirubin ≤ 2.5 mg/dL * Alanine transaminase (ALT) and Aspartate Aminotransferase (AST)\< 5 X upper limit of normal * Amylase or lipase ≤ 2X upper limit of normal * Serum creatinine ≤ 1.5 X upper limit of normal * International normalized ratio (INR) \< 2.0 Exclusion Criteria: * Main portal vein thrombosis * Eligible for curative treatment (ablation or transplantation) * History of previous or concurrent cancer other than HCC unless treated curatively 5 or more years prior to entry * Confirmed presence of extra-hepatic disease except lung nodules and mesenteric or portal lymph nodes ≤ 2.0 cm each * Risk of hepatic or renal failure * Tumor replacement ≥ 70% of total liver volume based on visual estimation by investigator OR tumor replacement ≥ 50% of total liver volume in the presence of albumin \<3 mg/dL * History of severe allergy or intolerance to contrast agents, narcotics s…