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USClinicalTrials.govClinical trialPhase 3Active, not recruiting

Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

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Official record

Identifier
NCT03847428
Recruiting locations

countries

United StatesAustraliaAustriaBrazilCanadaChinaEgyptFranceGermanyHong KongIndiaItalyJapanPeruPhilippinesPolandPuerto RicoRussiaSingaporeSouth KoreaTaiwanThailandTurkey (Türkiye)Vietnam
Interventions studied
DurvalumabBevacizumabPlacebo
Lead sponsor
AstraZeneca
Target enrolment
908 participants
Study type
INTERVENTIONAL
Phase
Phase 3
Status
Active, not recruiting
First posted
Feb 20, 2019
Last updated on the registry
Aug 14, 2026
Age
18 Years – 150 Years
Sex
ALL
Study contact
No public contact is listed on the official record.
Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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
Indexed under
Liver Cancer