A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Exclusion Criteria

• •History of leptomeningeal disease
• •Active or history of autoimmune disease or immune deficiency
• •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
• •Known active tuberculosis
• •History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
• •Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib
• •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• •Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding
• •A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment.
• •Moderate or severe ascites
• •History of hepatic encephalopathy
• •Co-infection of HBV and HCV
• •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• •Uncontrolled tumor-related pain
• •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• •Uncontrolled or symptomatic hypercalcemia
• •Treatment with systemic immunostimulatory agents
• •Inadequately controlled arterial hypertension
• •Prior history of hypertensive crisis or hypertensive encephalopathy
• •Evidence of bleeding diathesis or significant coagulopathy
• •History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration
• •Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
• •Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses
• •Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure
• •Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)