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Monoclonal Antibodies

Atezolizumab + Bevacizumab for Liver Cancer

Phase 4
Recruiting
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be eligible for liver transplantation, defined in Section 10.4
Histologically proven HCC, without extrahepatic disease. Patients who consent to a fresh tissue biopsy, and under the discretion of the Investigators, will provide a baseline biopsy sample for diagnosis and correlative studies. Archival tumor tissue may be used to confirm HCC in patients who do not consent to a fresh tissue biopsy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study enrollment to 1 year after liver transplant, time of liver transplant to 1 year after liver transplant
Awards & highlights

Study Summary

This trial will test whether a combination of two drugs can help treat liver cancer in patients who are eligible for transplantation. The drugs will be given for six months before the transplant procedure.

Who is the study for?
Adults with advanced liver cancer (HCC) outside Milan Criteria, eligible for a TACE procedure and liver transplant. They must have a life expectancy of at least 6 months, adequate organ function, no severe allergies to trial drugs or their components, and agree to use effective contraception. Excluded are those with recent significant cardiovascular issues, uncontrolled hypertension or bleeding disorders, certain infections like HIV or hepatitis B/C, other cancers within the last 5 years, previous HCC treatments before enrollment.Check my eligibility
What is being tested?
The trial tests if combining Atezolizumab and Bevacizumab with standard transarterial chemoembolization (TACE) can help patients with hepatocellular carcinoma beyond Milan Criteria safely reach liver transplantation without increasing post-transplant rejection risk.See study design
What are the potential side effects?
Potential side effects include high blood pressure; increased risk of bleeding; immune-related reactions that could affect organs like the lungs or intestines; fatigue; infusion reactions from the drug entering the body; allergic responses to drug components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for a liver transplant.
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My liver cancer is confirmed and hasn't spread outside the liver. I may provide a biopsy.
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My recent blood tests meet the study's health requirements.
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I had radiation therapy before, but my cancer has returned or spread.
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My liver functions well enough for treatment.
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I am fully active or can carry out light work.
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My liver function is good.
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I have not coughed up a significant amount of blood recently.
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I don't have severe varices and had an EGD test within the last 6 months.
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My liver cancer can be measured or evaluated by specific criteria and cannot be surgically removed.
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I am a candidate for and can undergo TACE procedures.
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I am 18 years old or older.
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My liver cancer can be measured or evaluated by specific criteria and cannot be surgically removed.
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I am fully active or can carry out light work.
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I am eligible for a liver transplant.
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I am 18 years or older and can sign a consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study enrollment to 1 year after liver transplant, time of liver transplant to 1 year after liver transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and study enrollment to 1 year after liver transplant, time of liver transplant to 1 year after liver transplant for reporting.

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 Receiving Liver Transplant Experiencing Acute Rejection
Secondary outcome measures
Immune Cell Biomarkers
Objective Response Rate
Overall survival after liver transplant
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Atezolizumab + BevacizumabExperimental Treatment2 Interventions
Patients will receive transarterial chemoembolization (TACE) every 3 months, with a maximum of 4 treatments, plus atezolizumab combined with bevacizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Atezolizumab
2016
Completed Phase 3
~6040

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
270 Previous Clinical Trials
80,224 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,729 Total Patients Enrolled
4 Trials studying Liver Cancer
140 Patients Enrolled for Liver Cancer

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05185505 — Phase 4
Liver Cancer Research Study Groups: Atezolizumab + Bevacizumab
Liver Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05185505 — Phase 4
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05185505 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment open for this research project?

"Clinicaltrials.gov suggests that this research project is not currently recruiting patients, as the trial was most recently updated on January 5th 2022 after being initially posted on March 17th 2022. Although no longer enrolling volunteers for this study, 2739 other clinical trials are actively seeking participants right now."

Answered by AI

Has the combination of Atezolizumab and Bevacizumab been given the green light by the FDA?

"With Phase 4 trials already conducted and approved, the safety of Atezolizumab + Bevacizumab was deemed a 3 on our team's evaluation scale."

Answered by AI
Recent research and studies
~16 spots leftby Apr 2027