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

Last updated: March 18, 2026
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

2

Condition

Digestive System Neoplasms

Liver Cancer

Carcinoma

Treatment

Bevacizumab

Transarterial Radioembolization (TARE)

Durvalumab

Clinical Study ID

NCT06040099
D933GC00002
  • Ages 18-130
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 liverremnant volume (FLRV) ≥ 30% of whole liver volume.

  • Participants with more than 1 prior embolization are permitted if more than 12months 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 participantswith segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) andeligible 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

Exclusion Criteria:

  • Disease amenable to curative surgery, ablation or transplantation. Transplantpatients are considered eligible if outside of Milan criteria and not currentlylisted 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 currentevidence 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, unstableangina, cerebrovascular accident, or transient ischemic attack, within 6 monthsprior to enrollment.

  • History of abdominal fistula or gastrointestinal (GI) perforation, non-healedgastric ulcer that is refractory to treatment, or active GI bleeding within 6 monthsprior to enrollment

Study Design

Total Participants: 58
Treatment Group(s): 3
Primary Treatment: Bevacizumab
Phase: 2
Study Start date:
February 13, 2024
Estimated Completion Date:
July 01, 2026

Study Description

A Phase II single-arm study conducted in participants with unresectable Hepatocellular carcinoma (HCC) eligible for embolization and not eligible for or who have declined treatment with resection and/or ablation or liver transplant.

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.

Connect with a study center

  • Research Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Research Site

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Research Site

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Research Site

    Miami, Florida 33136
    United States

    Site Not Available

  • Research Site

    Orlando, Florida 32804
    United States

    Site Not Available

  • Research Site

    Gainesville 4156404, Florida 4155751 32608
    United States

    Site Not Available

  • Research Site

    Miami 4164138, Florida 4155751 33176
    United States

    Site Not Available

  • Research Site

    Orlando 4167147, Florida 4155751 32804
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Research Site

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Research Site

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Research Site

    Boston 4930956, Massachusetts 6254926 02118
    United States

    Site Not Available

  • Research Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Research Site

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Research Site

    Trenton, New Jersey 08690
    United States

    Site Not Available

  • Research Site

    Trenton 5105496, New Jersey 5101760 08690
    United States

    Site Not Available

  • Research Site

    Buffalo, New York 14263
    United States

    Site Not Available

  • Research Site

    New York, New York 10029
    United States

    Site Not Available

  • Research Site

    Rochester, New York 14642
    United States

    Site Not Available

  • Research Site

    Buffalo 5110629, New York 5128638 14263
    United States

    Site Not Available

  • Research Site

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Research Site

    Rochester 5134086, New York 5128638 14642
    United States

    Site Not Available

  • Research Site

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Research Site

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • Research Site

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Research Site

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Research Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Research Site

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Research Site

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Research Site

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Research Site

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Research Site

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Site Not Available

  • Research Site

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

  • Research Site

    Seattle, Washington 98195
    United States

    Site Not Available

  • Research Site

    Seattle 5809844, Washington 5815135 98195
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Research Site

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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