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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
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
1,625 Previous Clinical Trials
937,205 Total Patients Enrolled
8 Trials studying Liver Cancer
2,851 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,916 Total Patients Enrolled
105 Trials studying Liver Cancer
26,544 Patients Enrolled for Liver Cancer
Aparna Kalyan, MDPrincipal InvestigatorNorthwestern University
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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.
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