Study to Improve the Effectiveness of Targeted TACE Therapy for Liver Cancer by Combining with the Active Ingredient Nicardipine

Summary description of the study

Liver cancer, also known as hepatocellular carcinoma (HCC), is the sixth most common tumor disease worldwide. It is an aggressive cancer that often leads to death, as it is usually diagnosed at a late stage when surgery is no longer possible. International guidelines recommend the so-called transarterial chemoembolization (TACE) as the treatment of choice in such cases, as this therapy can prolong survival. TACE is a widely used interventional method where a thin catheter is advanced to the tumor-supplying hepatic artery. Tiny beads loaded with a chemotherapy drug (Doxorubicin) are then injected directly into the tumor nodule. The beads block the tumor-supplying artery, interrupting the blood supply to the tumor, causing it to die. Additionally, the beads slowly release the chemotherapy drug Doxorubicin in the tumor, which is intended to contribute to the complete death of the tumor cells. However, studies have also shown that complete tumor nodule death was achieved in only about 25% of patients. Recent study results have clarified that one of the main reasons for the incomplete response to TACE therapy is that cancer cells develop resistances to protect themselves against the chemotherapy drug Doxorubicin. These resistances can be circumvented by inhibiting the enzyme ABCB1, allowing the chemotherapy drug to act within the tumor cells and lead to their complete death. The blood pressure medication Nicardipine has a strong inhibitory effect on this enzyme. Therefore, in this study, we aim to investigate whether the response to TACE therapy can be improved by administering beads that release not only the chemotherapy drug Doxorubicin but also the active ingredient Nicardipine in the tumor, preventing the tumor nodule from developing resistances and leading to complete death.

(BASEC)

Intervention under investigation

The study investigates TACE therapy, where the beads contain not only the chemotherapy drug Doxorubicin but also the blood pressure-lowering active ingredient Nicardipine, which supports the uptake of the chemotherapy drug into the tumor cells.

(BASEC)

Disease under investigation

Liver cancer

(BASEC)

Sponsor

Clarunis – Universitäres Bauchzentrum Basel

(BASEC)

Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee northwest/central Switzerland EKNZ

(BASEC)

Date of authorisation

25.06.2025

(BASEC)

Results of the trial