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Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
Trial Status: closed to accrual
A global study to assess the efficacy and safety of durvalumab in combination with
bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high
risk of recurrence.
Inclusion Criteria
Histologically or cytologically (or radiologically for patients undergoing curative ablation), 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.
Exclusion Criteria
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 HBV and HDV.
Receipt of prior systemic anticancer therapy for HCC
Those on a waiting list for liver transplantation
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03847428.
