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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 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.
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.
