Study on Atezolizumab, With or Without Bevacizumab, for Patients with Unremovable Liver Cancer and Certain Liver Conditions

Sponsor: Genentech, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06096779

Provider View

This clinical trial is testing the safety and effectiveness of the drug atezolizumab, alone or with bevacizumab, as a first treatment for patients with advanced liver cancer that cannot be removed by surgery and who have specific liver conditions known as Child-Pugh B7 or B8 cirrhosis.

Patient Parameters

Program Overview

The aim of this study is to see if the drug atezolizumab, either by itself or combined with bevacizumab, can safely and effectively treat patients with advanced liver cancer that cannot be surgically removed. The study focuses on patients who have not received any previous treatment for their cancer and have a specific type of liver condition called Child-Pugh B7 or B8 cirrhosis.

Description

This is a Phase II study, meaning it is focused on evaluating the safety and effectiveness of the treatment. It involves patients with advanced liver cancer that cannot be removed by surgery and who have a specific liver condition called Child-Pugh B7 or B8 cirrhosis. The study is open-label, meaning both the researchers and participants know which treatment is being given. Participants will be divided into two groups: one group will receive atezolizumab and bevacizumab together, while the other group will receive only atezolizumab. The study will take place at multiple centers and will not compare the two groups directly but will evaluate each treatment's safety and effectiveness separately.

Eligibility Criteria

Inclusion Criteria

  • Have advanced liver cancer that cannot be removed by surgery, confirmed by medical tests.
  • The cancer cannot be treated with surgery or other local treatments.
  • Have not received any previous treatment for advanced liver cancer.
  • Have at least one measurable tumor that has not been treated.
  • Be in relatively good health, with a performance status score between 0 and 2.
  • Have Child-Pugh B7 or B8 liver cirrhosis.
  • Have adequate blood and organ function.
  • Have a life expectancy of at least 12 weeks.
  • Women of childbearing age must agree to avoid pregnancy and not donate eggs during the study.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Previous treatment with certain immune therapies.
  • Recent treatment with experimental drugs or liver-targeted therapies.
  • Use of immune-boosting or immune-suppressing medications.
  • Recent vaccination with live vaccines.
  • Uncontrolled high blood pressure.
  • Active or past autoimmune diseases or immune deficiencies.
  • Lung diseases like pulmonary fibrosis or pneumonitis.
  • Other active cancers or significant cancer history.
  • Certain rare types of liver cancer.
  • Untreated or worsening brain cancer.
  • Previous organ transplants.
  • Listed for liver transplant.
  • Co-infection with hepatitis B and C.
  • Untreated or high-risk esophageal or stomach varices.
  • Recent serious bleeding events.
  • History of severe liver-related brain issues.
  • History of certain liver procedures or conditions.

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