Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment (EMERALD-2)

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

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

To learn more, visit ClinicalTrials.Gov

Study Type

Phase III

Principal Investigator(s)

Vikas Dembla, MD

Sponsor(s)

AstraZeneca