Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma

NCT07302919 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-02072, bb24heim
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepato Cellular Carcinoma (HCC)

Keywords

Transarterial Chemoembolization (TACE)

Outcome Measures

Primary Outcomes (2)

• complete response rate (CRR)

  of the target lesion at time point 3 months after TACE assessed by mRECIST (modified response evaluation criteria in solid tumors) in four-phase CT or contrast MRI according to standard liver imaging protocols

  3 month

• progression-free survival (PFS)

  as defined as time to progression of any tumor treated as part of the trial or death of a patient.

  up to 12 month

Secondary Outcomes (6)

• Objective response rate (ORR)

  3 month

• Duration of response (DOR)

  up to 12 month

• Change in tumor markers

  3 and 6 month

• Patient-reported outcomes

  up to 1 year

• Overall survival

  up to 12 month

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Combination Product: DEB-DoxNic-TACE

Control Arm

ACTIVE COMPARATOR

Combination Product: current standard of care

Interventions

DEB-DoxNic-TACE COMBINATION_PRODUCT

TACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads (DEB) loaded with 33mg/ml doxorubicin (Dox) and 0.3mg/mL nicardipine (Nic)

Experimental Arm

current standard of care COMBINATION_PRODUCT

TACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads loaded with 33mg/ml doxorubicin

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (3)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Study Officials

• Fahim Ebrahimi, PD Dr.

  University Hospital, Basel, Switzerland

  STUDY DIRECTOR

Central Study Contacts

Fahim Ebrahimi, PD Dr.

CONTACT

+41 61 777 74 00; fahim.ebrahimi@clarunis.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Parallel, Controlled, Multicenter Study

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: February 16, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

CH (3)