SBRT + Atezolizumab/Bevacizumab for Liver Cancer

Phase 1

Recruiting

Led By Edgar Ben-Josef, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to give radiation therapy to people with HCC. The hope is that it will be more effective than current methods.

Who is the study for?

This trial is for patients with advanced liver cancer (HCC) who can't have surgery or ablation due to the extent of disease, other health issues, or technical reasons and need systemic therapy.

What is being tested?

The study tests how safe and effective it is to give repeated doses of SBRT (a type of focused radiation therapy) along with two drugs, atezolizumab and bevacizumab, in treating liver cancer.

What are the potential side effects?

Possible side effects include fatigue, high blood pressure from bevacizumab; immune-related reactions like rash or inflammation from atezolizumab; and skin irritation or pain at the radiation site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Objective

Secondary study objectives

Overall Survival

Progression Free survival

Secondary Objective

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: study treatment planExperimental Treatment1 Intervention

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

0 / 1Eligibility criteria met