RecruitingPhase 1NCT05488522

SBRT With Atezo/Bev for HCC

A Phase I Study of SBRT Vaccination With Atezolizumab and Bevacizumab for Patients With Advanced Hepatocellular Carcinoma


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

18 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria1

  • 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 Criteria1

  • \-

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.


Locations(1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT05488522


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