SBRT With Atezo/Bev for HCC

NCT05488522 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 851667
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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)

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Primary 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.

  3 years

Secondary Outcomes (3)

• Secondary Objective

  3 years

• Overall Survival

  5 years

• Progression Free survival

  5 years

Study Arms (1)

study treatment plan

EXPERIMENTAL

Patients will be enrolled in a Rolling 6 clinical trial design1. This study design retains sensitivity to identifying DLTs while having the benefit of decreasing accrual time given the long DLT period required to assess radiation toxicity. In this trial design, up to 6 patients can be enrolled at a time onto a dose level while awaiting DLT assessment. Established rules guide the decision for enrolling onto the current, next highest, or previous dose level based on the number of participants currently enrolled in a given cohort, the number of radiation-attributable dose-limiting toxicities (ra-DLTs) observed, and the number of patients with immature toxicity data. If the MTD is not reached after 6 patients have enrolled on dose level 3 (three 17Gy fractions of SBRT) and have completed toxicity evaluations, then the recommended phase 2 dose will be determined based on an analysis of the efficacy of the combination

Biological: SBRT + atezolizumab and bevacizumab

Interventions

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.

study treatment plan

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery; atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Edgar Ben-Josef, MD

  Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edgar Ben-Josef, MD

CONTACT

215-615-6767; edgar.ben-josef@pennmedicine.upenn.edu

Taylor Siegal

CONTACT

taylor.siegal@pennemdicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 4, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)