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Trial Title:
SBRT With Atezo/Bev for HCC
NCT ID:
NCT05488522
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Atezolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
SBRT + atezolizumab and bevacizumab
Description:
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.
Arm group label:
study treatment plan
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)
Criteria for eligibility:
Criteria:
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:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Abramson Cancer Center of the University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104-4283
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Office - Abramson Cancer Center
Phone:
800-474-9892
Start date:
September 1, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05488522
