Clinical Research Trials

Key Trial Criteria

• Key Inclusion Criteria

  For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • Histologically or cytologically, newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
  • Imaging to confirm disease-free status within 28 days prior to randomization
  • ECOG 0-1 at enrolment
  • Child-Pugh score of 5 or 6
  • Adequate organ and marrow function

• Key Exclusion Criteria

  A patient will not be eligible for participation in this study if any of the following criteria apply.

  • Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
  • Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
  • History of hepatic encephalopathy within 12 months prior to randomization
  • Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
  • Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
  • Active co-infection with both HBV and HCV, or co-infected with HBV and hepatitis D virus
  • Receipt of prior systemic anticancer therapy for HCC
  • Those on a waiting list for liver transplantation