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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had an autoimmune disease that could come back.I have not received a live vaccine in the last 28 days.I have HIV and am on effective treatment.I have brain metastases that have not been treated.I may or may not have received previous treatments for my condition.I am currently on dialysis for kidney failure.I still have side effects from previous cancer treatments.I have a heart condition.I have liver cancer with a mild to moderate liver function score.My hepatitis B virus load is undetectable with treatment.I agree to use two forms of birth control if I can have children or am a non-sterilized, sexually active male.My blood, kidney, and liver functions are all within normal ranges.I do not have any uncontrolled illnesses.My advanced disease cannot be treated with surgery or transplant.I can take care of myself and am up and about more than half of my waking hours.I am allergic to certain cancer treatments like Y90, PD-1 & PD-L1 inhibitors, and TKIs.I have not had major surgery in the last 4 weeks.I can understand and am willing to sign the study's consent form.I have been treated with drugs targeting PDL1 or PD-1 before.I have had another cancer that got worse or needed treatment in the last 3 years.I had hepatitis C but have been treated and cured.I have received radiation therapy within the last 14 days.I haven't had chemotherapy, biologic, or hormonal therapy for cancer in the last 28 days.I have not had any gastrointestinal bleeding in the last 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Y90 + Atezolizumab and Bevacizumab
- Group 2: Y90 + TKI
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.
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
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