NCT07302919 Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma
| NCT ID | NCT07302919 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Hepato Cellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 152 participants in total. It began in 2026-02-16 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, * 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.
Contact & Investigator
Fahim Ebrahimi, PD Dr.
STUDY DIRECTOR
University Hospital, Basel, Switzerland
Frequently Asked Questions
Who can join the NCT07302919 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepato Cellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07302919 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07302919 currently recruiting?
Yes, NCT07302919 is actively recruiting participants. Contact the research team at fahim.ebrahimi@clarunis.ch for enrollment information.
Where is the NCT07302919 trial being conducted?
This trial is being conducted at Basel, Switzerland, Geneva, Switzerland, Sankt Gallen, Switzerland.
Who is sponsoring the NCT07302919 clinical trial?
NCT07302919 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Fahim Ebrahimi, PD Dr. at University Hospital, Basel, Switzerland. The trial plans to enroll 152 participants.