Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma

Korábbi kezelés

• Any prior systemic therapy for advanced HCC,
• Severe hypotension or hemodynamic shock or need of vasoactive medications,

Más betegség

• Decompensated heart failure New York Heart Association (NYHA) class IV,
• Myocardial infarction within the last 6 months,
• Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,

Laborértékek

• eGFR < 15 mL/min/1.73 m2 per MDRD (Modification of Diet in Renal Disease) formula,
• Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to calcium antagonists,

Egyéb

• Diffuse tumor lesions, extrahepatic metastases, or vascular invasion,
• Hepatic encephalopathy,
• Uncontrolled ascites or pleural effusion,
• Jaundice,
• Life expectancy <12 weeks,
• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 3 months after the TACE treatment.

• Informed consent as documented by signature,
• Age ≥18 years,
• Diagnosis of HCC by biopsy or by established imaging criteria using CT or MRI,
• At least one target lesion without prior treatment,
• Diameter of the target lesion ≥3 cm and ≤8 cm,
• Preserved liver function (no jaundice, no ascites, no overt hepatic encephalopathy).
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods for at least 3 months after the TACE treatment.