SBRT With Atezo/Bev for HCC
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Biological: SBRT + atezolizumab and bevacizumab
- Registration Number
- NCT05488522
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 18
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description study treatment plan SBRT + atezolizumab and bevacizumab 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 Measures
Name Time Method Primary Objective 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 Outcome Measures
Name Time Method Overall Survival 5 years we will be measuring for Overall Survival (OS) post study treatment.
Progression Free survival 5 years We will be measuring for progression free survival with RECIST 1.1 definition
Secondary Objective 3 years To assess efficacy and safety, in terms of tumor objective response rate (ORR) by RECIST 1.1 and iRECIST
Trial Locations
- Locations (1)
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States