Study on Therasphere® and Systemic Therapy for High-Risk Liver Cancer

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05620771

Provider View

This clinical trial is comparing two different treatments for advanced liver cancer after using Therasphere® (yttrium-90) therapy. The study will look at how well patients do with either immunotherapy or tyrosine kinase inhibitors.

Patient Parameters

Program Overview

The purpose of this study is to see which treatment works better for patients with advanced liver cancer after they receive Therasphere® (yttrium-90) therapy. The two treatments being compared are immunotherapy, which includes the drugs Atezolizumab and Bevacizumab, and tyrosine kinase inhibitors, which include Lenvatinib or Cabozantinib. The study will measure how long patients live without the cancer getting worse, among other outcomes.

Description

The main goal of this study is to compare how long patients with advanced liver cancer live without their cancer getting worse when treated with Therasphere® followed by either immunotherapy (Atezolizumab and Bevacizumab) or tyrosine kinase inhibitors (Lenvatinib or Cabozantinib). If patients have already been treated with Lenvatinib, they may receive Cabozantinib instead.

Secondary goals include comparing the time it takes for the cancer to start growing again, the response rate to the treatments, how long the response lasts, the overall benefit of the treatments, and overall survival rates. The study will also look at the safety and side effects of the treatments.

Patients will first receive Therasphere® treatment directed at the liver. After a recovery period of 14-21 days, they will start one of the systemic therapies. The study will follow patients for two years after they complete the treatment to monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of liver cancer (HCC) with a Childs-Pugh score of A or B7.
  • Must have at least one measurable tumor.
  • Cancer must be advanced and not suitable for surgery or transplant.
  • Can be new to treatment or have had previous treatments, but not prior cancer-targeted immunotherapy.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must have adequate organ function, including specific blood counts and liver and kidney function.
  • If HIV positive, must be on effective treatment.
  • If hepatitis B positive, must have an undetectable viral load on treatment.
  • If hepatitis C positive, must be treated and cured or have an undetectable viral load if on treatment.
  • Women of childbearing potential and men must agree to use two forms of contraception during and for 90 days after treatment.
  • Women must have a negative pregnancy test before starting the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot be enrolled in another clinical study unless it is observational.
  • Cannot have received other investigational drugs within 28 days before starting the study.
  • Cannot have severe allergies to similar drugs used in the study.
  • Cannot have had prior treatment with PD-L1 or PD-1 antagonists.
  • Cannot have another cancer that has progressed or required treatment in the last 3 years, with some exceptions.
  • Cannot have active or history of autoimmune diseases that may require treatment.
  • Cannot have kidney failure requiring dialysis.
  • Cannot have untreated brain or spinal cord cancer spread.
  • Cannot be receiving other cancer treatments within 28 days before starting the study.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot have received radiation therapy within 14 days before starting the study.
  • Cannot have received live vaccines within 28 days before starting the study.
  • Cannot have taken systemic steroids within 48 hours before starting the study.
  • Cannot have certain heart conditions or recent heart attacks.
  • Cannot have had major surgery within 4 weeks before starting the study.
  • Cannot have a history of gastrointestinal bleeding within 6 weeks before starting the study.
  • Cannot have had a transplant.
  • Cannot be pregnant or nursing.
  • Cannot have uncontrolled illnesses or conditions that would interfere with the study.

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