ACTIVE_NOT_RECRUITING

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

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Conditions

Hepatocellular Carcinoma (HCC)TAREDurvalumabBevacizumabLiver CancerY90

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-13
Study Completion:2027-01-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06040099

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.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with confirmed unresectable HCC
  2. * 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.
  3. * Participants with more than 1 prior embolization are permitted if more than 12 months ago, for a different primary lesion, and FLR \> 30%.
  4. * Participants with no evidence of extrahepatic disease on any available imaging
  5. * 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.
  6. * Participants having Child-Pugh score class A.
  7. * Participants having ECOG performance status of 0 or 1 at enrollment
  8. * Adequate organ and marrow function
  1. * Disease amenable to curative surgery, ablation or transplantation. Transplant patients are considered eligible if outside of Milan criteria and not currently listed for transplant.
  2. * Participants co-infected with HBV and HDV
  3. * Any history of nephrotic or nephritic syndrome.
  4. * Clinically significant (eg, active) cardiovascular disease
  5. * Participants with uncontrolled hypertension
  6. * History of hepatic encephalopathy
  7. * Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis.
  8. * Receipt of more than 1 prior embolization (TACE or TARE) treatment/procedure
  9. * Participant has received any prior anticancer systemic therapy for unresectable HCC.
  10. * History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment.
  11. * 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

Contacts and Locations

Study Locations (Sites)

Research Site
Aurora, Colorado, 80045
United States
Research Site
Gainesville, Florida, 32608
United States
Research Site
Orlando, Florida, 32804
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Atlanta, Georgia, 30342
United States
Research Site
Chicago, Illinois, 60611
United States
Research Site
Boston, Massachusetts, 02118
United States
Research Site
Detroit, Michigan, 48201
United States
Research Site
St Louis, Missouri, 63110
United States
Research Site
Trenton, New Jersey, 08690
United States
Research Site
Buffalo, New York, 14263
United States
Research Site
New York, New York, 10029
United States
Research Site
Chapel Hill, North Carolina, 27599
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Philadelphia, Pennsylvania, 19107
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Charlottesville, Virginia, 22908
United States
Research Site
Seattle, Washington, 98195
United States
Research Site
Milwaukee, Wisconsin, 53215
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-13
Study Completion Date2027-01-13

Study Record Updates

Study Start Date2024-02-13
Study Completion Date2027-01-13

Terms related to this study

Keywords Provided by Researchers

  • TARE
  • Durvalumab
  • Bevacizumab
  • Liver Cancer
  • Y90

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma (HCC)