Randomized, Double-Blind, Parallel, Controlled, Multicenter Study of Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma: IMPACT-TACE
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.
• 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.