A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE

Running, not enrolling · Phase 2

Conditions studied: Hepatocellular Carcinoma (HCC)

In brief

The purpose of this study is to measure the efficacy and safety of durvalumab intravenous (IV) solution plus bevacizumab IV solution after transarterial radioembolization (Yttrium 90 glass microspheres TARE) in participants with unresectable hepatocellular carcinoma (HCC) amenable to embolization.

Key facts

Study ID: NCT06040099
Run by: AstraZeneca
People needed: 58
Starts: 2024-02-13
Expected to finish: 2026-07-01
Last updated by the study team: 2026-06-30

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants with confirmed unresectable HCC
Participants with Lung dose threshold for Yttrium 90 glass microspheres of 30 Gy (equal or less than 30 Gy per treatment for glass) and an estimated Future liver remnant volume (FLRV) ≥ 30% of whole liver volume.
Participants with more than 1 prior embolization are permitted if more than 12 months ago, for a different primary lesion, and FLR > 30%.
Participants with no evidence of extrahepatic disease on any available imaging
Participants with one or more measurable lesions, unilobar disease for participants with segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) and eligible for Yttrium 90 glass microspheres TARE.
Participants having Child-Pugh score class A.
Participants having ECOG performance status of 0 or 1 at enrollment
Adequate organ and marrow function

You may not qualify if…

Disease amenable to curative surgery, ablation or transplantation. Transplant patients are considered eligible if outside of Milan criteria and not currently listed for transplant.
Participants co-infected with HBV and HDV
Any history of nephrotic or nephritic syndrome.
Clinically significant (eg, active) cardiovascular disease
Participants with uncontrolled hypertension
History of hepatic encephalopathy
Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis.
Receipt of more than 1 prior embolization (TACE or TARE) treatment/procedure
Participant has received any prior anticancer systemic therapy for unresectable HCC.
History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment.
History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment

Where it is running

Research Site — Aurora, Colorado, United States
Research Site — Gainesville, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Atlanta, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Boston, Massachusetts, United States
Research Site — Detroit, Michigan, United States
Research Site — St Louis, Missouri, United States
Research Site — Trenton, New Jersey, United States
Research Site — Buffalo, New York, United States
Research Site — New York, New York, United States
Research Site — Chapel Hill, North Carolina, United States
Research Site — Columbus, Ohio, United States
Research Site — Portland, Oregon, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Houston, Texas, United States
Research Site — Charlottesville, Virginia, United States
Research Site — Seattle, Washington, United States
Research Site — Milwaukee, Wisconsin, United States
Research Site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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