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Monoclonal Antibodies
Atezolizumab + Bevacizumab + SBRT for Liver Cancer
Phase 1
Waitlist Available
Led By Jennifer Y Wo, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-1
Age ≥18 years at the time of signing informed consent document
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights
Study Summary
This trial is looking at the safety and tolerability of the two drugs in combination with SBRT for treating unresectable hepatocellular carcinoma.
Who is the study for?
This trial is for adults with unresectable hepatocellular carcinoma (liver cancer), who have not had certain prior treatments, and whose liver function is relatively preserved (Child-Pugh A). They should have no more than 5 liver lesions, no severe portal hypertension or significant heart disease, and must not be pregnant or breastfeeding. Contraception use is required for participants of childbearing potential.Check my eligibility
What is being tested?
The study tests the combination of atezolizumab and bevacizumab drugs with stereotactic body radiation therapy (SBRT) to see if it's safe and tolerable for treating liver cancer that can't be removed by surgery. Participants will receive these medications alongside targeted radiation treatment.See study design
What are the potential side effects?
Potential side effects include high blood pressure, bleeding or bruising easily due to low platelet counts, fatigue, protein in urine, poor appetite, diarrhea; rare but serious risks involve gastrointestinal perforations and wound healing complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am 18 years old or older.
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I don't have high blood pressure in the liver veins.
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My organ and bone marrow functions are within normal ranges.
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My liver cancer cannot be treated with surgery, transplant, or RFA.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicity Rate
Secondary outcome measures
Change in Child-Pugh Score
In-field response rate
Out of field response rate
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic beam radiation therapy (SBRT) +Atezolizumab + BevacizumabExperimental Treatment3 Interventions
Study will begin with a safety lead of 6 participants to determine the maximum tolerated dose (MTD) of Stereotactic beam radiation therapy (SBRT) with atezolizumab and bevacizumab followed by study expansion to 14 more participants after maximum tolerated dose (MTD) is established.
Safety Lead-In: 6 cycles/18 weeks (study cycle is 3 weeks/21 days)
Cycle 1: Atezolizumab + Bevacizumab (1x) with Stereotactic beam radiation therapy (SBRT) every 1-3 days
Cycles 2-6: Atezolizumab + Bevacizumab (1x) every 3 weeks
Expanded Study:
Cycle 1: Atezolizumab + Bevacizumab (1x) with Stereotactic beam radiation therapy (SBRT) every 1-3 days
Cycles 2-End:Atezolizumab + Bevacizumab (1x) every cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Bevacizumab
FDA approved
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,669 Total Patients Enrolled
4 Trials studying Liver Cancer
140 Patients Enrolled for Liver Cancer
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,335 Total Patients Enrolled
6 Trials studying Liver Cancer
562 Patients Enrolled for Liver Cancer
Jennifer Y Wo, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had TACE or DEB treatments with a 2-week break before this trial.My liver is functioning well according to a recent test.My high blood pressure is not well controlled.I am fully active or can carry out light work.I am 18 years old or older.My liver cancer is at an intermediate or advanced stage.My liver cancer diagnosis was confirmed by a lab test within the last 6 months.I do not have any unmanaged ongoing illnesses.I don't have high blood pressure in the liver veins.I am currently taking or have recently taken certain medications.I have had a severe hypertension crisis or brain issues due to high blood pressure.I have not taken any immune-boosting drugs recently.I have not had a live vaccine recently.I have pain from my cancer that isn't managed well.I have high calcium levels in my blood that are causing symptoms.My cancer has spread directly into nearby organs.I have not had any cancer other than liver cancer in the last 5 years.I have a bleeding or clotting issue that needs treatment.I have varices that are at high risk of bleeding or have bled.I have specific health conditions or complications.I have not taken certain medications recently.My cancer has up to 5 tumors, none larger than 15 cm, and all together under 20 cm.I have not had a severe infection in the last 4 weeks.I have a history of lung conditions.I have not had major surgery recently.I have received systemic therapy before.My organ and bone marrow functions are within normal ranges.My cancer outside the liver is small, measuring less than 2.0 cm in total.I agree to use birth control if I can have children.My cancer has spread outside the liver or I have cancerous nodes larger than 2 cm.I have active tuberculosis.My liver cancer diagnosis was confirmed by lab tests within the last 6 months.My liver cancer cannot be treated with surgery, transplant, or RFA.I've had TACE or DEB treatment, but it's been at least 2 weeks since.I have not taken immunosuppressive drugs recently.I have brain metastases that are untreated or getting worse.I have a history of certain diseases or conditions.I frequently need procedures to remove excess fluid from my chest or abdomen.I have had a stem cell or organ transplant in the past.I have moderate to severe fluid buildup in my abdomen.I have a serious heart or blood vessel condition.My liver cancer is of a specific type.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic beam radiation therapy (SBRT) +Atezolizumab + Bevacizumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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 perils may arise from Atezolizumab usage?
"Due to sparse clinical evidence, the safety of Atezolizumab has been rated a 1 on our scale. This is because this Phase 1 trial offers limited data supporting both efficacy and security."
Answered by AI
Are there any openings left for participants in this experiment?
"This research is not currently taking on new volunteers. It was initially posted on the 1st of January 2022, and revised just last month in October 2021. If you are looking for other trials that may be a good fit, there are 2,597 clinical trails recruiting participants with carcinoma and 620 studies accepting applicants interested in Atezolizumab treatments."
Answered by AI
What therapeutic applications is Atezolizumab typically utilized for?
"Atezolizumab is typically prescribed for non-small cell lung carcinoma, however it may also be used to treat postoperative and recurrent cases of the same cancer as well as platinum-sensitive epithelial ovarian cancer."
Answered by AI
What precedent has been set for Atezolizumab-centric research?
"Currently, 620 research programmes are evaluating the efficacy of Atezolizumab; 142 of which have reached a Phase 3 status. With trials being administered in 31769 sites around the world, Taibei Taiwan is one major hub for this medication's investigation."
Answered by AI
What is the aggregate figure of individuals participating in this research?
"Unfortunately, this clinical trial is not currently enrolling. The research was initially posted on January 1st 2022 and last altered on October 26th 2021. On the other hand, there are presently 2597 experiments searching for participants with carcinoma and 620 trials seeking out those who would take Atezolizumab that require volunteers at this time."
Answered by AI
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