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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

Adequate hematological and end-organ function, defined by the following laboratory test results obtained within 14 days prior to study initiation: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Lymphocyte count ≥ 0.5 x 10^9/L (500/uL), Platelet count > 75 x 109/L, Hemoglobin > 9 g/dL, Total bilirubin < 1.5 x upper limit of normal (ULN), Aspartate transaminase (AST),alanine aminotransferase (ALT), and alkaline phosphatase (ALP) < 2.5 x ULN, Serum albumin > 2.7 g/dL, Serum creatinine < 1.5x ULN or calculated creatinine clearance < 50 ml/min, Urine dipstick for proteinuria ≥ 2+ unless a 24-hour urine protein < 1 g of protein is demonstrated, International normalized ratio (INR) ≤ 1.5 or partial thromboplastin time (PTT) ≤ 1.5 x ULN for patients not receiving anti-coagulation. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or PTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least two weeks prior to the first study treatment.

Must not have

Current treatment with anti-viral therapy for HBV

Previous systemic therapy for HCC prior to study enrollment

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

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

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.

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.

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 recent blood tests meet the study's health requirements.

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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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for hepatitis B.

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I have had treatment for liver cancer before joining this study.

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I have had a severe blood clot in the past.

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I have had or am planning to have a transplant involving multiple organs or a stem cell transplant.

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I have pain from my cancer that isn't relieved by treatment.

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I have previously been treated with specific immune therapies.

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I have active tuberculosis.

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I haven't had stomach or bowel inflammation in the last 6 months.

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I have a bleeding disorder that increases my risk of bleeding.

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I have not had major surgery or significant injury in the last 28 days and do not expect to need major surgery during the study.

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I have had an EGD for varices within the last 6 months or will have one before joining the study.

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I have had a severe hypertension crisis or brain issues due to high blood pressure.

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I haven't had a severe infection or been hospitalized for one in the last 4 weeks.

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I have had cancer spread to the lining of my brain and spinal cord.

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My calcium levels are normal and not causing symptoms.

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I am not allergic to Atezlizumab, Bevacizumab, or Chinese hamster ovary cell products.

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I frequently need procedures to remove excess fluid from my body.

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I haven't had major heart issues or strokes in the last 3 months.

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I have moderate to severe fluid buildup in my abdomen.

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I have not needed IV antibiotics for an infection in the last 2 weeks.

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I haven't had serious stomach or intestine issues, like bleeding or abscesses, in the last 6 months.

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My liver cancer is a specific type: fibrolamellar, sacromatoid, or mixed with bile duct cancer.

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I have had episodes of brain confusion due to liver problems.

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I have a serious wound or bone fracture that hasn't healed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study enrollment to 1 year after liver transplant, time of liver transplant to 1 year after liver transplant

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Patients Receiving Liver Transplant Experiencing Acute Rejection

Secondary study objectives

Immune Cell Biomarkers

Objective Response Rate

Overall survival after liver transplant

+6 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5540

Atezolizumab

2016

Completed Phase 3

~5860