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
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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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