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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT03847428

Run by

AstraZeneca

People needed

908

Starts

2019-04-29

Expected to finish

2027-05-31

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 150. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Mobile, Alabama, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Costa Mesa, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Orange, California, United States
• Research Site — Sacramento, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Miami, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Honolulu, Hawaii, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Westwood, Kansas, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Grand Rapids, Michigan, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — New Brunswick, New Jersey, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — New York, New York, United States
• Research Site — Stony Brook, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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