SBRT With Atezo/Bev for HCC

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT05488522
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

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 Details

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)

Key Dates

Start date
Sep 1, 2022
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: study treatment plan
    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

Primary Outcome Measure

Primary Objective [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-4283
Clinical Trials Office - Abramson Cancer Center
800-474-9892

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Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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