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Monoclonal Antibodies
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
Study 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.Check my eligibility
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.See study design
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Objective
Secondary outcome measures
Overall Survival
Progression Free survival
Secondary Objective
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
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,646 Total Patients Enrolled
1 Trials studying Liver Cancer
18 Patients Enrolled for Liver Cancer
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,046 Total Patients Enrolled
1 Trials studying Liver Cancer
18 Patients Enrolled for Liver Cancer
Edgar Ben-Josef, MDPrincipal InvestigatorAbramson Cancer Center
6 Previous Clinical Trials
212 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver cancer cannot be treated with surgery or ablation, and I need drug treatment.
Research Study Groups:
This trial has the following groups:- Group 1: study treatment plan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit to participate in this clinical trial more than 35 years old?
"Being included in this experiment necessitates that patients are between 18 and 99 years old. There are 85 studies for minors and 2583 for seniors."
Answered by AI
What is the current participant count of this clinical experiment?
"Affirmative. The information accessible on the clinicaltrials.gov website points to a medical trial that began in September 1st of 2022 and is currently open for recruitment, seeking 18 patients from one site."
Answered by AI
Is there an opportunity for me to participate in this experiment?
"For enrollment into this study, individuals must meet the criteria of being between 18 and 99 years old while exhibiting liver carcinoma. At present, our research team is aiming to find at least 18 participants."
Answered by AI
Is enrollment for this research currently open?
"This research experiment, originally published on September 1st 2022 and updated as recently as the 16th of the same month, is actively looking for volunteers. The information can be found on clinicaltrials.gov."
Answered by AI
Has the experimental approach been sanctioned by the federal regulators?
"As this is a Phase 1 trial, there is minimal evidence to substantiate the safety and effectiveness of the proposed treatment plan. Our team at Power assigned it an overall score of 1 on our risk scale."
Answered by AI
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