A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma - EMERALD-1

Inclusion Criteria

• - No evidence of extrahepatic disease
• - Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
• - Child-Pugh score class A to B7 and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
• - Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
• - Adequate organ and marrow function
• Key Exclusion Criteria
• - Any history of nephrotic or nephritic syndrome
• - Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization
• - Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion)
• - History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
• - Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded