A Phase 2/3 interventional study of DEB-DoxNic-TACE and current standard of care in Hepato Cellular Carcinoma (HCC), sponsored by University Hospital, Basel, Switzerland. Recruiting at 3 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by University Hospital, Basel, Switzerland · Phase 2/3, Interventional, and Treatment
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.
Liver cancer, also known as hepatocellular carcinoma (HCC), is the sixth most common tumor disease worldwide. It is an aggressive cancer that is very often fatal, as it is usually detected at a late stage when surgery is no longer possible. International guidelines recommend transarterial chemoembolization (TACE) as the treatment of choice in such cases, as this therapy can prolong survival. In such cases, international guidelines recommend transarterial chemoembolization (TACE) as the treatment of choice, as this therapy can prolong survival. TACE is a widely used interventional method in which a thin catheter is advanced to the liver artery supplying the tumor. Tiny beads loaded with a chemotherapeutic agent (doxorubicin) are then injected directly into the tumor nodules. The beads block the artery supplying the tumor, interrupting the blood supply to the tumor and causing it to die. In addition, the beads slowly release the chemotherapy drug doxorubicin into the tumor, which is intended to contribute to the complete death of the tumor cells. However, the studies also showed that complete death of the tumor node could only be achieved in approximately 25% of patients. The latest study results have revealed that one of the main causes of the incomplete response to TACE therapy is that cancer cells develop resistance to protect themselves against the chemotherapy drug doxorubicin. This resistance can be circumvented by inhibiting the enzyme ABCB1, allowing the chemotherapy drug to act on the tumor cells and kill them completely. The blood pressure medication nicardipine has a strong inhibitory effect on this enzyme. In this study, the investigators therefore want to investigate whether the response to TACE therapy can be improved by administering beads that release the active ingredient nicardipine in the tumor in addition to the chemotherapy drug doxorubicin, so that the tumor nodule cannot develop resistance and dies completely.
University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Combination Product: DEB-DoxNic-TACE
Combination Product: current standard of care
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
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
Time frame: 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.
Time frame: up to 12 month
Objective response rate (ORR)
Objective response (complete and partial) of the target lesion at time point 3 months assessed by mRECIST (modified response evaluation criteria in solid tumors).
Time frame: 3 month
Duration of response (DOR)
Time frame: up to 12 month
Change in tumor markers
Time frame: 3 and 6 month
Patient-reported outcomes
EuroQol 5-Dimension Questionnaire; 5-level version (EQ-5D-5L). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame: up to 1 year
Overall survival
Time frame: up to 12 month
Complete response of the target lesion
Time frame: 6 month
Plan to share: Undecided
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University Hospital, Basel, Switzerland