Study of Atezolizumab and Bevacizumab With Y-90 TARE in Patients With Unresectable Hepatocellular Carcinoma (HCC)

PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

November 30, 2020

Primary Completion Date

June 18, 2023

Study Completion Date

June 30, 2023

Conditions
Hepatocellular Carcinoma
Interventions
OTHER

Y-90 TARE

"This plan will involve treating the predominant liver lesions with segment Y-90 TARE using predetermined dosimetry, while keeping FLR equal or greater than 40% (FLR is estimated by excluding the liver volume of Y-90 infused distribution).~The maximal amount of Y-90 TARE treatment will be limited to only one lobe of the liver if segmental Y-90 TARE is not possible to treat the predominant lesion. Since segmental Y-90 TARE may result in less long term liver damage compared to lobal Y-90 TARE, segmental Y-90 TARE treatment is preferred to lobar Y-90 TARE if segmental Y-90 TARE treatment is able to treat all blood supply to the predominant lesion or lesion with vascular invasion to preserve liver function. For segmental treatment, a minimum tumor dose of 190 Gy should be used for glass microspheres and 120 Gy for resin microspheres. For lobar treatment, a minimum dose of 100 Gy should be used for resin microspheres."

DRUG

Atezolizumab

Atezolizumab 1200 mg will be delivered as an IV infusion on Day 1 of each cycle (every 3 weeks). The initial dose will be delivered over 60 (± 15) minutes and if tolerated subsequent infusions may be given over 30 minutes.

DRUG

Bevacizumab

Bevacizumab 15 mg/kg will be delivered as an IV infusion on Day 1 of each 3 week cycle.The initial dose will be delivered over 90 minutes (±15 minutes) and if tolerated subsequent infusions may be given over 60 minutes

Trial Locations (6)

14263

Roswell Park Cancer Institute, Buffalo

20057

Georgetown University, Washington D.C.

21201

University of Maryland, Baltimore

33612

Moffitt Cancer Center, Tampa

37232

Vanderbilt-Ingram Cancer Center, Nashville

02118

Boston Medical Center, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Georgetown University

OTHER

collaborator

Genentech, Inc.

INDUSTRY

lead

Aiwu Ruth He, MD

OTHER