- Diagnosis of locally advanced or metastatic HCC, obtained by histology/cytology (on a
prior tumor biopsy) or by imaging with serum α-fetoprotein (AFP) ≥400 ng/mL.
- All patients must provide at least 1 archival tumor specimen. If archival tumor
specimen is no longer available, de novo tumor biopsy will be required during
- HCC not amenable to local therapy.
- Measurable disease according to RECIST v. 1.1.
- Child Pugh Class A disease.
- BCLC stage B or C disease.
- No evidence of uncontrolled hypertension as documented by 2 baseline blood pressure
readings taken at least 1 hour apart.
- ECOG performance status 0 or 1.
- Adequate bone marrow function, renal and liver functions
- Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) as assessed by
multigated acquisition (MUGA) scan or echocardiogram (ECHO).
- Prior systemic treatment for advanced HCC, including prior treatment with approved or
- Any prior locoregional therapy within 4 weeks and radiotherapy or surgical procedure
within 2 weeks (4 weeks for major surgery) of enrollment.
- Patients with known symptomatic brain metastases requiring steroids.
- Presence of hepatic encephalopathy (ie, Child Pugh score of 2 or 3) and/or clinically
relevant ascites (ie, Child Pugh score of 3).
- Presence of main portal vein invasion by HCC.
- Any of the following within the 12 months prior to enrollment: myocardial infarction,
severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic
congestive heart failure, LVEF less than LLN, clinically significant pericardial
effusion, cerebrovascular accident, transient ischemic attack.
- Active infection requiring systemic therapy except for hepatitis C virus (HCV) and
hepatitis B virus (HBV).