Study on Atezolizumab and Bevacizumab with TACE for Patients with Intermediate Stage Liver Cancer

Sponsor: Yale University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05776875

Provider View

This clinical trial is exploring a new treatment combination for patients with intermediate stage liver cancer (HCC) that cannot be cured with surgery. The study aims to see if adding the drugs atezolizumab and bevacizumab to a procedure called TACE can improve treatment outcomes.

Patient Parameters

Program Overview

This study is investigating a new approach for treating intermediate stage liver cancer (HCC) by combining two drugs, atezolizumab and bevacizumab, with a procedure called Transarterial Chemoembolization (TACE). The goal is to see if this combination can help the immune system better fight the cancer, not just in the liver but throughout the body. This approach is being tested because current treatments for this stage of liver cancer are limited, and there is a need for more effective options.

Description

Atezolizumab is a drug that helps the immune system attack cancer cells by targeting a specific pathway. It has shown promise in treating various cancers, including lung, kidney, and bladder cancers. Bevacizumab is another drug that works by cutting off the blood supply to tumors, which can help shrink them. Both drugs have been studied together in liver cancer, showing positive results in previous trials.

This trial will include patients with intermediate stage liver cancer who are not candidates for surgery but can undergo TACE, a procedure that delivers chemotherapy directly to the liver tumor. The study will assess whether the combination of atezolizumab and bevacizumab with TACE can improve outcomes for these patients.

Participants will be monitored for side effects and the effectiveness of the treatment. The study aims to provide new insights into whether this combination can offer better control of liver cancer and improve patients' quality of life.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • No severe liver disease or only mild cirrhosis (Child-Pugh A).
  • Diagnosed with liver cancer (HCC) that meets specific criteria for intermediate stage.
  • Must have good liver, bone marrow, and kidney function based on lab tests.
  • Eligible for TACE treatment, which can be done in up to 4 sessions.
  • If positive for Hepatitis B, must have an undetectable viral load or start antiviral treatment before the study.
  • Can have untreated Hepatitis C.
  • Must have at least one measurable tumor.
  • Must meet specific blood count and organ function criteria.
  • Women of childbearing potential must agree to use effective contraception during and after treatment.
  • Men must agree to use condoms or abstain from intercourse during and after treatment.
  • Must be able to comply with the study protocol and have a life expectancy of at least 6 months.

Exclusion Criteria

  • Signs or history of severe liver failure, such as confusion or bleeding from varices.
  • Uncontrolled Hepatitis B infection.
  • History of severe high blood pressure or related complications.
  • Candidates for curative treatments like surgery or liver transplant.
  • Recent severe liver complications, such as fluid buildup or confusion.
  • Cancer spread outside the liver, except for small, stable lymph nodes.
  • Previous treatments for liver cancer, except for certain procedures.
  • Specific types of liver cancer, like fibrolamellar or mixed types.
  • Blockage of major liver blood vessels.
  • Pregnant or breastfeeding women.
  • Known allergies to study drugs or similar medications.
  • History of autoimmune diseases, except for certain controlled conditions.
  • Active infections like tuberculosis or severe recent infections.
  • Significant heart or lung diseases.
  • Recent major surgery or planned surgery during the study.
  • Recent use of certain medications or treatments that could interfere with the study.
  • Other serious medical conditions that could affect participation or safety in the study.

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