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

Description

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.

Conditions

Hepatocellular Carcinoma (HCC)

Study Overview

Study Details

Study overview

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.

Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere™) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy

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

Condition
Hepatocellular Carcinoma (HCC)
Intervention / Treatment

-

Contacts and Locations

Aurora

Research Site, Aurora, Colorado, United States, 80045

Gainesville

Research Site, Gainesville, Florida, United States, 32608

Miami

Research Site, Miami, Florida, United States, 33136

Miami

Research Site, Miami, Florida, United States, 33176

Orlando

Research Site, Orlando, Florida, United States, 32804

Atlanta

Research Site, Atlanta, Georgia, United States, 30322

Atlanta

Research Site, Atlanta, Georgia, United States, 30342

Chicago

Research Site, Chicago, Illinois, United States, 60611

Boston

Research Site, Boston, Massachusetts, United States, 02118

Detroit

Research Site, Detroit, Michigan, United States, 48201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 liver remnant volume (FLRV) ≥ 30% of whole liver volume
  • * 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
  • * Disease amenable to curative surgery or transplantation or curative ablation.
  • * 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

Ages Eligible for Study

18 Years to 130 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-10-23