Hepatocellular Carcinoma
Conditions
Brief summary
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)
Interventions
BIOLOGICALSBRT + atezolizumab and bevacizumab
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.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have hepatocellular carcinoma (HCC) that is not amenable to curative-intent surgical or ablation (where surgery or ablation are not indicated due to disease extent, co-morbidities, or other technical reasons) and systemic therapy is indicated.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Objective | 3 years | To assess efficacy and safety, in terms of tumor objective response rate (ORR) by RECIST 1.1 and iRECIST |
| Overall Survival | 5 years | we will be measuring for Overall Survival (OS) post study treatment. |
| Progression Free survival | 5 years | We will be measuring for progression free survival with RECIST 1.1 definition |
Countries
United States
Contacts
CONTACTEdgar Ben-Josef, MD
CONTACTTaylor Siegal
PRINCIPAL_INVESTIGATOREdgar Ben-Josef, MD
Abramson Cancer Center
Outcome results
None listed