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Monoclonal Antibodies
Atezolizumab + Bevacizumab + Y-90 TARE for Liver Cancer
Phase 2
Waitlist Available
Led By Aiwu R He, MD, PhD
Research Sponsored by Aiwu Ruth He, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological evidence/confirmation per AJCC, 8th edition, of hepatocellular carcinoma (HCC)
Age ≥ 18 years at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is looking at whether adding bevacizumab and atezolizumab to Y90 TARE improves treatment of unresectable advanced stage HCC.
Who is the study for?
Adults with advanced, inoperable liver cancer (HCC) who haven't had prior systemic therapy. They must have a good performance status and liver function (Child-Pugh score A or selected B7), no history of certain severe health conditions, not be pregnant or breastfeeding, and willing to use contraception. Candidates should understand the study procedures and agree to follow them.Check my eligibility
What is being tested?
This phase II trial is testing if adding atezolizumab and bevacizumab after Y-90 TARE treatment improves outcomes for patients with unresectable HCC compared to Y-90 TARE alone. Participants are randomly assigned to one of these two approaches in an open-label setting across multiple centers.See study design
What are the potential side effects?
Possible side effects include high blood pressure from bevacizumab, immune-related reactions from atezolizumab such as inflammation in organs, infusion reactions, fatigue, digestive issues like diarrhea or nausea, increased risk of infections due to weakened immune response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer diagnosis is confirmed by lab tests.
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I am 18 years old or older.
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My liver function is classified as Child-Pugh A or B7.
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I am a man who can father children and agree to use birth control or abstain from sex.
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I have not had any systemic therapy before.
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I am eligible for TARE treatment based on lung and liver health criteria.
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I am fully active or can carry out light work.
Select...
My liver, kidneys, and bone marrow are functioning well.
Select...
I am willing to use birth control or abstain from sex.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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) by RECIST 1.1
Secondary outcome measures
Incidence and severity of adverse events
Overall Response Rate (ORR) by mRECIST
Overall survival (OS)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm BExperimental Treatment3 Interventions
TARE then Bevacizumab and Atezolizumab
Group II: Arm AActive Control1 Intervention
TARE alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Aiwu Ruth He, MDLead Sponsor
1 Previous Clinical Trials
4 Total Patients Enrolled
Georgetown UniversityOTHER
343 Previous Clinical Trials
136,496 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,683 Total Patients Enrolled
4 Trials studying Liver Cancer
140 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver cancer diagnosis is confirmed by lab tests.I am not eligible for or have refused a liver transplant.I have an autoimmune disease treated with medication in the last 2 years.I am a woman who can have children and have a recent negative pregnancy test.I am eligible for TARE treatment based on lung and liver health criteria.My liver, kidneys, and bone marrow are functioning well.I still have side effects from previous cancer treatments.I have not had signs of liver failure like fluid in the abdomen, confusion, or bleeding from enlarged veins in my stomach or esophagus in the last six months.I frequently need procedures to remove excess fluid from my chest or abdomen.I have untreated or partially treated varices in my esophagus or stomach that are bleeding or at high risk of bleeding.I had bleeding from varices in my esophagus or stomach in the last 6 months.I cannot have Y-90 treatment due to specific blood flow issues in my liver and/or gastrointestinal tract.My high blood pressure is not well-controlled.I have had a severe hypertension crisis or brain issues due to high blood pressure.I haven't had major heart problems or unstable heart conditions in the last 3 months.My liver cancer is of a specific rare type.I haven't had major surgery in the last 4 weeks and don't plan to during the study.I have had a transplant before, either stem cell or an organ.I have had lung scarring or inflammation not caused by infections.I have not been treated with specific immune therapies like anti-CTLA-4, anti-PD-1, or anti-PD-L1.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.I have pain from my cancer that isn't relieved by treatment.I have cancer that has spread to my brain.I have or had cancer other than liver cancer, but it meets certain exceptions.I haven't had major blood vessel problems in the last 6 months.I have not coughed up blood in the last month.I have a serious illness that is not under control.I am currently taking or have recently taken aspirin or certain blood thinners.I am currently on or recently used blood thinners for treatment.I have not had a severe infection in the last 4 weeks.I have active tuberculosis.I haven't had a live vaccine within 30 days before or 180 days after the study treatment.I am 18 years old or older.My liver function is classified as Child-Pugh A or B7.I am a man who can father children and agree to use birth control or abstain from sex.I understand and can follow the study's procedures.My liver cancer is at an advanced stage but hasn't spread beyond my liver.I have not had any systemic therapy before.I am fully active or can carry out light work.I am willing to use birth control or abstain from sex.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm A
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.
Are there any available appointments for this research project?
"That is correct. Currently, the clinical trial is accepting applications from patients. The listing on clinicaltrials.gov shows that the study was initially posted on November 30th 2020 and updated July 1st, 2022. There are 6 sites which will each host 128 participants."
Answered by AI
How many people are sign ups for this clinical trial?
"In order to properly conduct this clinical trial, we need 128 participants that fit the pre-specified inclusion criteria. Luckily, patients can choose to participate at different locations such as Boston Medical Center or Georgetown University."
Answered by AI
What other cancer treatments have included Y-90 TARE in the past?
"As of now, there are 645 ongoing studies researching Y-90 TARE with 153 trials in Phase 3. While some of the trials for Y-90 TARE are based in Taibei, Taiwan, there are 34168 locations conducting clinical trials for Y-90 TARE globally."
Answered by AI
For what purpose is Y-90 TARE commonly prescribed?
"Y-90 TARE is a treatment option for non-small cell lung carcinoma, recurrent platinum-sensitive epithelial ovarian cancer, and other conditions."
Answered by AI
In how many hospitals is this research being conducted?
"There are a total of 9 locations for this trial, which are Boston Medical Center in Boston, Massachusetts, Georgetown University in Washington, District of Columbia, Vanderbilt-Ingram Cancer Center in Nashville, Tennessee and 6 other sites."
Answered by AI
Could you please explain the risks associated with Y-90 TARE?
"While there is some data suggesting that Y-90 TARE is safe, as this is only a Phase 2 trial, Power rates it as a 2."
Answered by AI
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