Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

The study population includes patients 18 years of age or older with advanced HCC, Barcelona
Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh
A classification liver disease. Patients must not have received any prior systemic therapy
for unresectable HCC.

Patients in all treatment arms may continue receiving their originally assigned treatment, at
the Investigator's discretion, until progression

Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to
receive benefit from their assigned treatment and meet the criteria for treatment in the
setting of PD may continue to receive their assigned treatment.

If a patient discontinues study drug(s) due to disease progression, the patient will enter
survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic
deterioration or who have commenced subsequent anticancer therapy, will have tumor
assessments until confirmed PD and will be followed for survival.

Inclusion criteria

- HCC based on histopathological confirmation

- No prior systemic therapy for HCC

- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional
therapy) or stage C

- Child-Pugh Score class A

- ECOG performance status of 0 or 1 at enrollment

Exclusion criteria

- Hepatic encephalopathy within past 12 months or requirement for medication to prevent
or control encephalopathy

- Clinically meaningful ascites

- Main portal vein tumor thrombosis

- Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding)
within 12 months

- HBV and HVC co-infection, or HBV and Hep D co-infection