Study on Atezolizumab and Bevacizumab Versus Monitoring for Preventing Return of Liver Cancer After Surgery or Ablation

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04102098

This clinical trial is testing whether a combination of two drugs, atezolizumab and bevacizumab, can help prevent the return of liver cancer after surgery or ablation, compared to just monitoring the patient.

Patient Parameters

Program Overview

The purpose of this study is to find out if using the drugs atezolizumab and bevacizumab together can help stop liver cancer from coming back after it has been completely removed or treated with ablation. The study will compare this drug combination to simply keeping a close watch on the patient without additional treatment.

Eligibility Criteria

Inclusion Criteria

  • First-time diagnosis of liver cancer that has been completely removed by surgery or treated with ablation (a procedure using heat to destroy cancer cells) within 4-12 weeks before joining the study.
  • No major cancer spread to blood vessels or other parts of the body, confirmed by scans.
  • Fully recovered from surgery or ablation at least 4 weeks before joining the study.
  • High risk of cancer returning after treatment.
  • If post-surgery chemoembolization was done, full recovery at least 4 weeks before joining.
  • Available tumor tissue sample from surgery.
  • Good overall health with a performance status of 0 or 1.
  • Good liver function (Child-Pugh Class A).
  • Adequate blood and organ function.
  • Women who can have children must agree to use birth control or abstain from sex.
  • Men must agree to use condoms or abstain from sex and not donate sperm.

Exclusion Criteria

  • Specific types of liver cancer like fibrolamellar, sarcomatoid, or mixed types.
  • Evidence of cancer remaining, returning, or spreading at the time of joining the study.
  • Significant fluid buildup in the abdomen (ascites).
  • History of brain-related liver disease (hepatic encephalopathy).
  • Recent bleeding from untreated esophageal or stomach veins.
  • More than one cycle of post-surgery chemoembolization.
  • Active or past autoimmune diseases or immune deficiencies.
  • Lung diseases like pulmonary fibrosis or pneumonia.
  • Recent serious heart problems or unstable heart conditions.
  • Other cancers within the last 5 years, except for low-risk types.
  • Active tuberculosis.
  • Any condition that makes the study drugs unsafe or complicates treatment.
  • Pregnant or breastfeeding women, or those planning to become pregnant during or shortly after the study.
  • Co-infection with hepatitis B and C or hepatitis D.
  • Uncontrolled high calcium levels in the blood.
  • Previous treatment for liver cancer before surgery or ablation.
  • Use of immune system-affecting drugs.
  • Uncontrolled high blood pressure.
  • History of severe high blood pressure events.
  • Significant blood vessel diseases.
  • Bleeding disorders or blood clotting issues.
  • Recent use of blood thinners or aspirin.
  • Recent major surgery or non-healing wounds.
  • Daily use of certain anti-inflammatory drugs.

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