Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma
Recruiting now · Phase 2/Phase 3
Conditions studied: Hepato Cellular Carcinoma (HCC)
In brief
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.
Key facts
- Study ID
- NCT07302919
- Run by
- University Hospital, Basel, Switzerland
- People needed
- 152
- Starts
- 2026-02-16
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-03-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University Hospital Basel — Basel, Switzerland (enrolling)
- Hôpitaux Universitaires de Genève — Geneva, Switzerland (enrolling)
- Kantonsspital St. Gallen — Sankt Gallen, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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