An official website of the United States government
A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE
Trial Status: active
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.
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 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
Disease amenable to curative surgery, ablation or transplantation. Transplant patients are considered eligible if outside of Milan criteria and not currently listed for transplant.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06040099.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Illinois
Chicago
Northwestern University
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not Available
Oregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available
Pennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not Available
Virginia
Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not Available
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
