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Monoclonal Antibodies
SBRT + Atezolizumab + Bevacizumab for Liver Cancer
Phase < 1
Recruiting
Led By Joseph W Franses, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years at the time of signing the informed consent document
No prior therapy directed against the index hepatocellular carcinoma lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to end of treatment, up to 2 years
Awards & highlights
Study Summary
This trial is looking at how well neoadjuvant SBRT (a type of radiation therapy) with atezolizumab and bevacizumab (two cancer-fighting drugs) work in treating resectable hepatocellular carcinoma (a type of liver cancer). Researchers want to see if this neoadjuvant therapy combination is safe and tolerable.
Who is the study for?
This trial is for adults with resectable hepatocellular carcinoma (a type of liver cancer) who have good liver function (Child-Pugh A), no history of certain bleeding events or severe allergies, and are not pregnant. They must be able to understand the study and consent to it, have measurable disease without vascular invasion, and agree to use contraception.Check my eligibility
What is being tested?
The trial tests the combination of SBRT (a precise form of radiation therapy), Atezolizumab, Bevacizumab, followed by surgery in patients with resectable liver cancer. It aims to assess how safe this treatment sequence is and how well patients tolerate it.See study design
What are the potential side effects?
Possible side effects include high blood pressure from Bevacizumab; immune-related reactions like inflammation or infusion reactions from Atezolizumab; fatigue; risk of infection; potential damage to nearby organs from SBRT.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have not received any treatment for my liver cancer lesion.
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I have a tumor that can be measured and is at least as big as specified.
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I have not received any treatment for my liver cancer lesion.
Select...
I have a tumor that can be measured with imaging or physical exam.
Select...
I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.
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My liver cancer is operable and hasn't spread into major blood vessels.
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My heart condition is stable or mild.
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My liver functions well despite my condition.
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I can carry out all my self-care but cannot do heavy physical work.
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I am mostly self-sufficient and can carry out daily activities.
Select...
My liver functions well despite my condition.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to end of treatment, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to end of treatment, 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
Proportion of patients with grade 3-4 treatment-related adverse events as assessed by CTCAE v5.0
Secondary outcome measures
Complete response (CR)
Objective response rate (ORR)
Overall survival (OS)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic beam radiation therapy (SBRT) +Atezolizumab + BevacizumabExperimental Treatment3 Interventions
Participants will:
undergo a pre-treatment biopsy with fiducial marker placement
receive Stereotactic beam radiation therapy (SBRT) on three treatment days which will be arranged on an every-other-day basis
receive two 3-week (21 days) cycles of atezolizumab plus bevacizumab
receive Atezolizumab on day 1 for 2 study cycles.
receive Bevacizumab 1x weekly for 2 study cycles
Surgery after SBRT and the two cycles of atezolizumab and bevacizumab, unless participants are otherwise informed by their doctor. The planned surgery will take place 6-8 weeks after the last infusions of atezolizumab and bevacizumab.
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?
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,420 Total Patients Enrolled
6 Trials studying Liver Cancer
562 Patients Enrolled for Liver Cancer
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,879 Total Patients Enrolled
4 Trials studying Liver Cancer
140 Patients Enrolled for Liver Cancer
Joseph W Franses, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The number of certain white blood cells in your body, called neutrophils, must be at least 1,500 per microliter.I am 18 years old or older.I have not received any treatment for my liver cancer lesion.I have had lung conditions like pulmonary fibrosis or pneumonitis.I haven't taken any immune-weakening drugs in the last 2 weeks.You have enough white blood cells in your body (at least 3,000/mcL).I have another cancer that won't affect this treatment's safety or results.I have not had a severe infection in the last 4 weeks.I have a tumor that can be measured and is at least as big as specified.I haven't taken any immune-boosting drugs in the last month.My liver cancer is only in the liver, can be removed by surgery, and has been recently confirmed.I have a serious wound that won't heal, an active ulcer, or an untreated broken bone.I have not received any treatment for my liver cancer lesion.I have unexplained air in my abdomen not due to recent procedures.I have had a severe hypertension crisis or brain issues due to high blood pressure.I have a tumor that can be measured with imaging or physical exam.I have active tuberculosis.You are allergic or have a strong sensitivity to any of the study drugs or their ingredients.I had bleeding from esophageal or stomach varices in the last 6 months.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I do not have cancer that has spread to my brain or other distant parts of my body.I am currently on or recently used blood thinners for treatment.My organs and bone marrow are working well.I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.My cancer has spread to lymph nodes or other areas beyond the liver.I agree to use birth control during the study.My liver cancer is a specific type: fibrolamellar, sarcomatoid, or mixed.I am currently taking or have recently taken high-dose aspirin or certain blood thinners.I haven't had major surgery or serious injury in the last 28 days, or abdominal surgery or injury in the last 60 days.My liver cancer is operable and hasn't spread into major blood vessels.I have not had any cancer other than liver cancer in the last 5 years.I have had a blockage in my intestines before.My cancer has not spread to my portal veins, or if it has, it's only a vp1 tumor thrombus.Your platelet count should be at least 100,000 cells per microliter.My heart condition is stable or mild.I take NSAID medication every day for a chronic condition.I have not had any abdominal inflammation in the last 6 months.You have or had a condition that affects your immune system or ability to fight off diseases.I have not coughed up blood in the last month.I have not had significant blood vessel problems in the last 6 months.My liver functions well despite my condition.I can carry out all my self-care but cannot do heavy physical work.My high blood pressure is not well controlled.I have untreated or partially treated varices in my esophagus or stomach that may bleed.I haven't had major heart problems in the last 3 months.I had a biopsy or minor surgery within the last 3 days.I am mostly self-sufficient and can carry out daily activities.My liver functions well despite my condition.I am 18 years old or older.I have not received a live vaccine in the last 4 weeks.I have had or am waiting for a stem cell or organ transplant.You are currently taking part in another study involving experimental drugs.I haven't had any major stomach or throat issues in the last 6 months.I don't have any health issues that prevent me from taking new medications.Your bilirubin levels must not exceed twice the normal limit.I have had severe liver-related brain issues or fluid in my abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic beam radiation therapy (SBRT) +Atezolizumab + Bevacizumab
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.
Is this trial enrolling new participants currently?
"Per the information on clinicaltrials.gov, this scientific investigation is currently in search of enrollees. The study's first posting occurred on 18th June 2021 and its last update was issued 10th February 2022."
Answered by AI
To which ailments is Bevacizumab typically administered?
"Bevacizumab has proven successful in treating non-small cell lung carcinoma, recurrent platinum-sensitive ovarian cancer, and postoperative recurrences of non-squamous non-small cell lung malignancy."
Answered by AI
How many participants have been selected for this research endeavor?
"Affirmative. Clinicaltrials.gov possesses information that confirms the active recruitment of participants for this trial, which began on June 18th 2021 and was very recently updated on February 10th 2022. The medical study is seeking 20 individuals to join from a single site."
Answered by AI
Has Bevacizumab been subjected to any other investigations?
"Currently, there are 620 different studies conducted on Bevacizumab. Amongst these investigations, 142 have reached Phase 3 and the sites for these trials mainly reside in Taipei, Taiwan; however 31781 locations worldwide host related research."
Answered by AI
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