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Monoclonal Antibodies
Atezolizumab + Bevacizumab for Liver Cancer (AB7 Trial)
Phase 2
Waitlist Available
Led By Kristen Spencer, DO, MPH
Research Sponsored by Kristen Spencer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 1 untreated measurable lesion according to RECIST 1.1
Locally advanced, metastatic, or unresectable hepatocellular carcinoma that has not received prior systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
AB7 Trial Summary
This trial will study the safety of combining atezolizumab and bevacizumab in patients with advanced liver cancer who have not received prior systemic therapy.
Who is the study for?
This trial is for adults with advanced liver cancer (Hepatocellular Carcinoma) who haven't had systemic therapy before. They should have a specific level of liver dysfunction (Child-Pugh B7 or B8), be able to perform daily activities with little help, and agree to use contraception. People can't join if they're on high-dose steroids, have certain heart or lung conditions, uncontrolled other diseases, or are expected to need treatment for another cancer within two years.Check my eligibility
What is being tested?
The study tests the safety of combining Atezolizumab and Bevacizumab in patients with advanced liver cancer. It's a single group trial where all participants receive both drugs without being compared to another treatment or placebo.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that may affect organs, infusion-related reactions from the drug entering the body, increased risk of infections due to immune system suppression, bleeding issues because Bevacizumab affects blood vessels, and potential hypertension.
AB7 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one cancer spot that hasn't been treated yet.
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My liver cancer is advanced or inoperable and I haven't had systemic therapy.
Select...
My cancer's genetic test was done on stored or newly taken tissue.
Select...
I am fully active or can carry out light work.
Select...
My liver is not working well but it's not the worst case.
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I am 18 years old or older.
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I agree to use contraception or remain abstinent.
AB7 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and severity of toxicities
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Median overall survival (OS)
+2 moreAB7 Trial Design
1Treatment groups
Experimental Treatment
Group I: Study TreatmentExperimental Treatment2 Interventions
Atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Kristen SpencerLead Sponsor
1 Previous Clinical Trials
78 Total Patients Enrolled
Howard S. HochesterLead Sponsor
Howard S HochsterLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have significant fluid buildup in my abdomen.I do not have another cancer that needs treatment within 2 years.I have at least one cancer spot that hasn't been treated yet.I have had radiation for any painful cancer spots before joining.I frequently need procedures to remove fluid from around my lungs or heart.I have active tuberculosis.My liver cancer is of a specific rare type.I haven't had cancer treatment or been part of a study in the last 3 weeks.I have high calcium levels in my blood that are causing symptoms.I have previously received immunotherapy.I have significant confusion or memory problems.I have pain from my cancer that isn't relieved by medication.I still have side effects from previous cancer treatments.I have had lung conditions like pulmonary fibrosis or pneumonitis.I have had a solid organ or bone marrow transplant in the past.I am willing to have a new tumor biopsy if it's safe.My liver cancer is advanced or inoperable and I haven't had systemic therapy.My cancer's genetic test was done on stored or newly taken tissue.I am fully active or can carry out light work.I am taking high doses of steroids or other drugs for an autoimmune disease.I have untreated brain or spinal cord disease.I have not had a serious infection in the last 2 weeks.My liver is not working well but it's not the worst case.I have had kidney disorders involving protein in the urine or inflammation.My high blood pressure is not controlled, even with maximum treatment.I am currently taking medication that weakens my immune system.I have no health issues that prevent me from taking new medications.I have not received a live vaccine in the last 4 weeks.I have previously been treated with specific immune therapies.I have had treatment for liver cancer before.My bone marrow and organs are functioning well.I am 18 years old or older.I agree to use contraception or remain abstinent.
Research Study Groups:
This trial has the following groups:- Group 1: Study Treatment
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.
Can you provide more information about other Atezolizumab research?
"As of right now, there are 645 clinical trials underway that involve Atezolizumab. 153 of those studies are in Phase 3. However, the majority of these trials take place in Taibei, Taiwan with 34168 other locations running similar tests."
Answered by AI
Could you please give an estimate of how many people are participating in this clinical trial?
"That is correct. The clinical trial is still recruiting patients, as of the most recent update on September 9th, 2022. Originally, the study was posted on March 22nd, 2021 and is looking for a total of 50 individuals from 5 different sites."
Answered by AI
What is the Atezolizumab FDA status?
"Atezolizumab's safety was rated a 2 because, while there is some evidence to support its safety from Phase 2 trials, there is no data currently available regarding the efficacy of the medication."
Answered by AI
Is this trial also running in any other Canadian provinces?
"The primary locations running this study are Indiana University Melvin and Bren Simon Comprehensive Cancer Center, University of Illinois Cancer Center, and Rutgers Cancer Institute of New jersey; although, there are 5 other sites participating."
Answered by AI
What are the conditions that Atezolizumab is most commonly used to target?
"Atezolizumab is used to treat a variety of conditions, including non-small cell lung carcinoma, postoperative recurrent non-squamous non-small cell lung cancer, and platinum-sensitive epithelial ovarian cancer."
Answered by AI
Are there any unfilled positions in this research project?
"Yes, according to the latest information from clinicaltrials.gov, this research is still looking for volunteers. The project was initially posted on March 22nd, 2021 and was updated as recently as September 9th, 2022. At present, 50 people are needed at 5 different locations."
Answered by AI
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