A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE
Liver Cancer / Hepatoblastoma
18 - 130 Years, Male and Female
D933GC00002 (primary)
NCI-2023-10167
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.
Objectives
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 125 participants with unresectable but amenable to locoregional therapy HCC
eligible for embolization will be enrolled in the study at approximately 20 sites in the
US to treat approximately 100 participants.
Eligibility
- 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
Treatment Sites in Georgia
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