Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma
Randomized, Double-Blind, Parallel, Controlled, Multicenter Study of Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma: IMPACT-TACE
University Hospital, Basel, Switzerland
152 participants
Feb 16, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria13
- 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,
- Myocardial infarction within the last 6 months,
- Life expectancy \<12 weeks,
- Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to calcium antagonists,
- Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 3 months after the TACE treatment.
Interventions
TACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads (DEB) loaded with 33mg/ml doxorubicin (Dox) and 0.3mg/mL nicardipine (Nic)
TACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads loaded with 33mg/ml doxorubicin
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07302919