Table 2.

Key inclusion and exclusion criteria of IMbrave 150 trial in patients with hepatocellular carcinoma.

Inclusion Criteria:
-Locally advanced/unresectable or metastatic disease with a minimum of one measurable lesion and no central nervous system metastatic disease or invasion of tumor to major blood vessels or airways -No prior exposure to systemic therapy -Good baseline performance status (ECOG score 0 or 1) -Adequate hematologic and end-organ function without significant medical comorbidities -Child–Pugh class A -No active or bleeding varices on upper GI endoscopy
Exclusion Criteria:
-Presence of fibrolamellar or sarcomatoid histologies; co-existing or concurrent malignancies such as cholangiocarcinoma; history of other malignancies with considerable risk of morbidity or death within the last 5 years -Presence or a history of leptomeningeal disease or autoimmune conditions -History or presence of pulmonary disease such as idiopathic pulmonary fibrosis (IPF), drug induced or idiopathic chronic pneumonitis -Infections: Co-existing hepatitis B and C virus infections; Human immunodeficiency virus (HIV) infections -Presence of untreated or partially treated esophageal varices with high risk of bleeding -Pregnancy or breast-feeding females -Worsening cirrhosis leading to moderate to severe ascites and hepatic encephalopathy -Recurrent third spacing of fluids needing frequent drainage procedures -Uncontrolled high blood pressure, bleeding diathesis or coagulopathy, hypercalcemia, or non-healing open wounds -Receipt of liver-directed therapy within the last 28 days or lingering side effects from such procedure performed beyond 28 days -Chronic therapy with non-steroidal anti-inflammatory agents (NSAID)