A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE
NCT ID: NCT06040099
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-02-13
2026-10-23
Brief Summary
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Detailed Description
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Participants with previous Transarterial Chemoembolization (TACE) or TARE associated with the curative setting are permitted with a 6-month washout.
Approximately 120 participants with unresectable but amenable to locoregional therapy HCC eligible for embolization will be screened in the study at approximately 20 sites in the US to enroll approximately 60 participants.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Yttrium 90 glass microspheres TARE in combination with Durvalumab and Bevacizumab
Participants will undergo Yttrium 90 glass microspheres TARE according to the dosimetry recommendation.
Durvalumab
Durvalumab IV (intravenous)
Bevacizumab
Bevacizumab IV (intravenous)
Transarterial Radioembolization (TARE)
Yttrium 90 glass microspheres will be administered
Interventions
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Durvalumab
Durvalumab IV (intravenous)
Bevacizumab
Bevacizumab IV (intravenous)
Transarterial Radioembolization (TARE)
Yttrium 90 glass microspheres will be administered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Aurora, Colorado, United States
Research Site
Gainesville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, 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
Rochester, 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
Fairfax, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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D933GC00002
Identifier Type: -
Identifier Source: org_study_id