A Phase II study of Atezolizumab and Bevacizumab in Child-Pugh B7 and B8 Hepatocellular Carcinoma (The AB7 Trial)
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Krishnan, Mridula
Eligibility: https://clinicaltrials.gov/study/NCT04829383?term=NCT04829383&rank=1
Summary
1 Primary Objective
To estimate the safety of the combination of atezolizumab and bevacizumab in patients with
advanced/metastatic HCC and Child-Pugh B7 and B8 liver dysfunction by grade 3-5 adverse
event rate.
.2 Secondary Objectives
To estimate the efficacy of the combination in this patient population by overall response rate
(ORR), disease control rate (DCR), duration of response (DOR), progression free survival (PFS),
and overall survival (OS).
3 Correlative/Exploratory Objectives
To correlate tumor molecular signature from next generation sequencing (NGS) tissue analysis
with clinical outcomes and treatment response.
To correlate tumor molecular signature from NGS tissue analysis with ctDNA.
To correlate levels of ctDNA with clinical outcomes and treatment response