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Monoclonal Antibodies

Therasphere + Systemic Therapy for Liver Cancer

Phase 2
Recruiting
Led By Aparna Kalyan, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For patients with a known history of Human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy
Patients must have a diagnosis of hepatocellular carcinoma (HCC) confirmed by American Association for Study of Liver Diseases (AASLD) guidelines with a Childs-Pugh score of A or B7
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial aims to compare the effectiveness of two cancer treatments in adult patients with advanced liver cancer after Therasphere® treatment.

Who is the study for?
Adults with advanced hepatocellular carcinoma (liver cancer) who are not candidates for transplant or surgery. They must have a good performance status, measurable disease, and well-managed HIV or hepatitis if present. Women of childbearing age and sexually active men must use two contraception methods. Excluded are those with recent cancers, dialysis patients, untreated brain metastases, vaccine recipients within 28 days, pregnant/nursing women, allergy to trial drugs/components, prior PD-1/PD-L1 therapy users.Check my eligibility
What is being tested?
The study compares the effectiveness of Therasphere® (Y90 radiotherapy) followed by either immunotherapy (Atezolizumab + Bevacizumab) or tyrosine kinase inhibitors (Lenvatinib/Cabozantinib). The goal is to see which treatment better prevents liver cancer from progressing.See study design
What are the potential side effects?
Possible side effects include immune-related reactions due to Atezolizumab/Bevacizumab such as inflammation in organs; high blood pressure; bleeding issues; fatigue; liver problems from Y90 therapy; and hand-foot syndrome typically associated with TKI's.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have HIV and am on effective treatment.
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I have liver cancer with a mild to moderate liver function score.
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My hepatitis B virus load is undetectable with treatment.
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I agree to use two forms of birth control if I can have children or am a non-sterilized, sexually active male.
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I had hepatitis C but have been treated and cured.
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My blood, kidney, and liver functions are all within normal ranges.
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My advanced disease cannot be treated with surgery or transplant.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Adverse Events
Clinical Benefit Rates (CBR)
Duration of Response (DOR)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Y90 + TKIExperimental Treatment1 Intervention
Group II: Y90 + Atezolizumab and BevacizumabExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,580 Previous Clinical Trials
916,763 Total Patients Enrolled
8 Trials studying Liver Cancer
2,851 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,263 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Aparna Kalyan, MDPrincipal InvestigatorNorthwestern University

Media Library

Atezolizumab and Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05620771 — Phase 2
Liver Cancer Research Study Groups: Y90 + Atezolizumab and Bevacizumab, Y90 + TKI
Liver Cancer Clinical Trial 2023: Atezolizumab and Bevacizumab Highlights & Side Effects. Trial Name: NCT05620771 — Phase 2
Atezolizumab and Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05620771 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What implications does the combination of Y90, Atezolizumab and Bevacizumab have for patient health?

"Our team at Power gave Y90 + Atezolizumab and Bevacizumab a score of 2 in terms of safety, as the trial is only on Phase 2. This means that there is some data to support these treatments' security but none documenting their efficacy yet."

Answered by AI

Are there any vacancies for individuals to participate in this test?

"According to the clinicaltrials.gov page, this medical study is not currently accepting participants; it was first posted on November 25th 2022 and last updated on November 11th 2022. Nonetheless, there are 2,608 alternative trials actively recruiting patients at this time."

Answered by AI
~13 spots leftby Jul 2024