Histologically or cytologically (or radiologically for patients undergoing curative ablation) confirmed Locoregional Hepatocellular Carcinoma (HCC) and successfully completed curative therapy (resection or Ablation) MedDRA version: 20.0 Level: LLT Classification code 10077746 Term: Hepatocellular carcinoma stage I System Organ Class: 100000004864
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation) 2.Imaging to confirm disease-free status within 28 days prior to randomization 3.ECOG 0-1 at enrolment 4.Child-Pugh score of 5 or 6 5.Patients with HBV infection must receive antiviral therapy at least after enrollment per institutional practice to ensure adequate viral suppression prior to randomization. Patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study Treatment. 6.Patients with HCV infection must be managed per local institutional practice for the study and for 6 months after the last dose of study treatment. 7.Adequate organ and marrow function, as defined by the CSP Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 533 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 355
Exclusion criteria
Exclusion criteria: 1.Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC 2.Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging 3.History of hepatic encephalopathy within 12 months prior to randomization 4.Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging 5.Patients with Vp1 to Vp4 portal vein thrombosis on baseline Imaging are excluded. 6. Active co-infection with both HBV and HDV 7.Receipt of prior systemic anticancer therapy for HCC 8.Those on a waiting list for liver transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of durvalumab in combination with bevacizumab compared to placebo in terms of Recurrence-free survival (RFS);Secondary Objective: Arm A: Durvalumab + bevacizumab Arm B: Durvalumab + placebo Arm C: Placebo -To compare the efficacy of Arm A versus Arm C in terms of RFS - To assess the efficacy of durvalumab in combination with bevacizumab compared to placebo in terms of Recurrence-free survival (RFS);Primary end point(s): RFS;Timepoint(s) of evaluation of this end point: Assessments for RFS will be collected regularly at predefined time points until disease recurrence or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS) Time to recurrence (TTR) RFS at 24 months (RFS24 ) Time from randomization to recurrence/progression on next therapy (RFS2/PFS2);Timepoint(s) of evaluation of this end point: Assessments will be made regularly until disease recurrence, death, or until the end of the study | — |
Countries
Australia, Austria, Brazil, Canada, China, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Peru, Poland, Taiwan, Thailand, Turkey, United States
Contacts
Public ContactStudy Information Center
AstraZeneca Clinical
Outcome results
None listed