Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma
Trial Parameters
Brief Summary
IMPACT-TACE is an investigator-initiated, prospective, multicenter, randomized, double-blinded, interventional trial to test the hypothesis that the simultaneous application of doxorubicin with the ABCB1 inhibitor nicardipine would significantly improve the success rate of TACE treatment.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Any prior systemic therapy for advanced HCC, * Diffuse tumor lesions, extrahepatic metastases, or vascular invasion, * Hepatic encephalopathy, * Uncontrolled ascites or pleural effusion, * Jaundice, * Severe hypotension or hemodynamic shock or need of vasoactive medications, * Decompensated heart failure New York Heart Association (NYHA) class IV, * eGFR \< 15 mL/min/1.73 m2 per MDRD (Modification of Diet in Renal Disease) formula, *