Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
- Trial number:
-
NCT03847428
- Trial phase:
- 3
- Study type:
- Immunotherapy, Targeted therapy
- Overall status:
- Active, not recruiting
Study start date
Scientific title
Summary
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.
Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCCEvidence 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 design
Conditions
Other study ID numbers
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