Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Hepatocellular Carcinoma
Age (in years)
18 - 150
Phase
Phase 3
Participants needed
908
Est. Completion Date
Aug 31, 2025
Treatment type
Interventional
Sponsor
AstraZeneca
ClinicalTrials.gov identifier
NCT03847428
Study number
D910DC00001
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