Study on Regorafenib and Yttrium-90 Radioembolization for Liver Cancer That Cannot Be Removed by Surgery

Sponsor: University of Miami

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06902246

This clinical trial is exploring the effects of combining the drug Regorafenib with Yttrium-90 radioembolization to treat liver cancer that cannot be surgically removed.

Patient Parameters

Program Overview

The aim of this study is to find out how well the combination of Regorafenib, a cancer medication, and Yttrium-90 (Y-90) radioembolization, a type of radiation therapy, works in treating patients with liver cancer that cannot be removed by surgery.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Have liver cancer that cannot be surgically removed.
  • Have a liver function score of Child-Pugh A-B7.
  • Have specific blood test results showing:
    • Bilirubin levels less than 1.5 times the normal limit.
    • Liver enzymes (AST and ALT) less than 5 times the normal limit.
    • Creatinine levels less than or equal to 1.5 times the normal limit.
    • Blood clotting times (INR/PTT) less than or equal to 1.5 times the normal limit. Patients on blood thinners like warfarin or heparin can participate if they have no clotting issues.
    • Platelet count over 100,000/mm3, hemoglobin at least 9 g/dL, and neutrophil count at least 1,500/mm3.
  • A test shows that radioembolization can be safely performed.
  • No previous systemic treatment for liver cancer.
  • Agree to follow contraception guidelines during the study.

Exclusion Criteria

  • A test shows blood vessel issues that prevent radioembolization.
  • Have had radioembolization before.
  • Have major disease outside the liver.
  • Have cancer that has spread to the brain.
  • Have not recovered from major surgery or plan to have major surgery within 30 days of joining the study.
  • Have a non-healing wound, ulcer, or bone fracture.
  • Have HIV or active hepatitis B or C needing antiviral treatment.
  • Have an ongoing severe infection.
  • Have uncontrolled high blood pressure despite treatment.
  • Have significant heart disease, including:
    • Severe heart failure.
    • Active heart disease.
    • Heart rhythm issues needing treatment other than beta blockers or digoxin.
    • Unstable chest pain or recent heart attack.
  • Have a history of bleeding disorders.
  • Have had a severe bleeding event recently.
  • Have had recent blood clots or strokes.
  • Have another untreated or active cancer, except for certain non-threatening types.
  • Have impaired decision-making ability.

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