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,
Any prior systemic therapy for advanced HCC,
Diffuse tumor lesions, extrahepatic metastases, or vascular invasion,
Hepatic encephalopathy,
Uncontrolled ascites or pleural effusion,