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NCT Number: NCT05488522

SBRT With Atezo/Bev for HCC

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)

Recruiting

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location status: Recruiting

Location contact

Clinical Trials Office - Abramson Cancer Center

CONTACT

800-474-9892

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

SBRT + atezolizumab and bevacizumab

Biological

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.

Primary outcomes

  1. Primary Objective

    Time frame: 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 outcomes

  1. Secondary Objective

    Time frame: 3 years

    To assess efficacy and safety, in terms of tumor objective response rate (ORR) by RECIST 1.1 and iRECIST

  2. Overall Survival

    Time frame: 5 years

    we will be measuring for Overall Survival (OS) post study treatment.

  3. Progression Free survival

    Time frame: 5 years

    We will be measuring for progression free survival with RECIST 1.1 definition

Study contacts

Contact information is provided by the study sponsor or research team.

Edgar Ben-Josef, MD

CONTACT

[email protected]

215-615-6767

Taylor Siegal

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2022
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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