A phase I dose escalation and pharmacodynamic study of repeated dose stereotactic body radiotherapy (SBRT) administered with concurrent atezolizumab and bevacizumab for patients with advanced hepatocellular carcinoma (HCC)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Stereotactic Body Radiotherapy (SBRT) is a radiation procedure that delivers precise doses of radiation in fractions. See following section for more information on the schedule, dose, volume, and simulation of SBRT. Atezolizumab is an FDA-approved immune checkpoint inhibitor that is used in the treatment of advanced HCC. It is administered as a flat-dose 1200 mg intravenous infusion every three weeks. Bevacizumab is an FDA-approved anti-VEGF monoclonal antibody that is used in the treatment of advanced HCC in combination with atezolizumab. It is administered as a weight-based dose of 15 mg/kg intravenous infusion every 3 weeks.
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGPrimary Objective
we will measure the total number of subjects that can tolerate the recommended phase II regimen of SBRT with atezolizumab/bevacizumab (atezo/bev) in patients with advanced hepatocellular carcinoma and the proportion of patients experiencing a radiation-attributable DLT at each dose level.
Time frame: 3 years
Secondary Objective
To assess efficacy and safety, in terms of tumor objective response rate (ORR) by RECIST 1.1 and iRECIST
Time frame: 3 years
Overall Survival
we will be measuring for Overall Survival (OS) post study treatment.
Time frame: 5 years
Progression Free survival
We will be measuring for progression free survival with RECIST 1.1 definition
Time frame: 5 years
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