Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04541173
Status:
TERMINATED
Last Update Posted:
2024-06-05
First Post:
2020-09-01
Brief Title:
Study of Atezolizumab and Bevacizumab With Y-90 TARE in Patients With Unresectable Hepatocellular Carcinoma HCC
Sponsor:
Aiwu Ruth He MD
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Randomized Phase II Study of Atezolizumab and Bevacizumab With Y-90 TARE in Patients With Unresectable Hepatocellular Carcinoma HCC
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multi-center randomized phase II study comparing the Y90 TARE followed by bevacizumab and atezolizumab treatment to the Y90 TARE treatment alone in unresectable advanced stage HCC
Detailed Description:
Subjects will be randomized to Y-90 TARE alone Arm A or Y-90 TARE followed by the combination of atezolizumab and bevacizumab Arm B The first 10 subjects randomized to Arm B Y-90 TARE bevacizumab atezolizumab will be assessed for safety after two cycles If there are no Grade 3 unexpected toxicities possibly probably or definitely related to TARE in combination with bevacizumab and atezolizumab the combination will be deemed safe and accrual will resume
Subjects randomized to receive bevacizumab and atezolizumab Arm B will start the combination of bevacizumab and atezolizumab 4 weeks 1 week after TARE treatment Full recovery from the procedure is required prior to systemic treatment
AST and ALT 5 x upper limit of normal ULN and total bilirubin 3 mgdL
Manifestations of post-embolization syndrome eg fever nausea vomiting and abdominal pain have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events Version 50 Grade 1
No significant medical events eg gastrointestinal GI bleeding cardiac events hepatorenal syndrome during or after the TARE procedure
Arm B subjects will continue the study drugs for a total of 24 months from the TARE treatment until intolerable toxicity or disease progression occur
Subjects randomized to receive bevacizumab and atezolizumab Arm B will start the combination of bevacizumab and atezolizumab 4 weeks 1 week after TARE treatment Full recovery from the procedure is required prior to systemic treatment
AST and ALT 5 x upper limit of normal ULN and total bilirubin 3 mgdL
Manifestations of post-embolization syndrome eg fever nausea vomiting and abdominal pain have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events Version 50 Grade 1
No significant medical events eg gastrointestinal GI bleeding cardiac events hepatorenal syndrome during or after the TARE procedure
Arm B subjects will continue the study drugs for a total of 24 months from the TARE treatment until intolerable toxicity or disease progression occur
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None