Key Inclusion Criteria

  • Unresectable Hepatocellular Carcinoma (HCC)
    • Barcelona Clinic Liver Cancer (BCLC) stage C with or without portal vein thrombosis not eligible for surgical resection, liver transplantation nor Radiofrequency ablation (RFA), or
    • BCLC stage A/B
      • Patients with recurrence of HCC after surgical or loco-regional treatment not eligible for surgical resection, liver transplantation or RFA, or
      • Patients who have not achieved an objective response after ≤2 sessions of Transarterial Chemoembolisation (TACE) in the target lesions
  • Eastern Cooperative Oncology Group (ECOG) performance status 0–1
  • If cirrhosis is present, Child-Pugh class A or B ≤7 points
  • Adequate haematological, renal and hepatic function
  • Life expectancy >3 months

Key Exclusion Criteria

  • Concurrent or previous malignancy other than adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
  • Extrahepatic metastases (except non-specific pulmonary tumours <1 cm and abdominal lymph nodes <2 cm)
  • Advanced HCC previously treated with systemic therapy (does not preclude prior TACE or other loco-regional/radical therapies)
  • Advanced liver disease with Child-Pugh score >B7, active gastrointestinal bleeding, encephalopathy or refractory ascites
  • Pregnant or breast feeding

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