Status:
ACTIVE_NOT_RECRUITING
Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
Lead Sponsor:
AstraZeneca
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-150 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2027
Estimated Enrollment :
908 Patients enrolled
Trial Details
Trial ID
NCT03847428
Start Date
April 29 2019
End Date
May 31 2027
Last Update
December 5 2025
Active Locations (217)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Mobile, Alabama, United States, 36604
3
Research Site
Phoenix, Arizona, United States, 85054
4
Research Site
Costa Mesa, California, United States, 92627