SBRT and Durvalumab for Inoperable/Unresectable Hepatocellular Carcinoma

Inclusion criteria

• ✓. Patients must have histologically or radiologically confirmed HCC. For radiological diagnosis of HCC, a contrast-enhanced computed tomography or magnetic resonance imaging is mandatory to demonstrate the early arterial enhancement in arterial phase and contrast washout in the porto-venous phase on the imaging.
• ✓. Inoperable or unresectable non-metastatic HCC (in the form of tumor resection or liver transplantation) amenable to stereotactic body radiation therapy given in 5 fractions. Prior locoregional therapy including radiofrequency ablation, transarterial chemoembolisation, radioembolisation is allowed provided that radiologically progressive disease is demonstrated following these locoregional therapies.
• ✓. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorisation (e.g. Health Insurance Portability and Accountability Act in the US, European Union \[EU\] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• ✓. Be \>/= 18 years of age on day of signing informed consent.
• ✓. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
• ✓. A stage C or earlier HCC based on Barcelona Clinic Liver Cancer (BCLC) staging system.
• ✓. A Child-Pugh of 7 or less.
• ✓. Demonstrate adequate organ function as defined in Inclusion Criteria 7, all screening labs should be performed 28 days prior to study registration up to the first dose of study drug.

Exclusion criteria