Randomized, Double-Blind, Parallel, Controlled, Multicenter Study of Transarterial Chemoembolization Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating whether adding the ABCB1 inhibitor nicardipine to the standard transarterial chemoembolization TACE treatment can improve outcomes for patients with hepatocellular carcinoma HCC, a common and aggressive liver cancer often detected too late for surgery. The trial tests the idea that this combination may increase the success rate of TACE by overcoming tumor resistance to the chemotherapy drug doxorubicin. This is a prospective, randomized, double-blinded, multicenter interventional trial sponsored by the University Hospital Basel in Switzerland. The study compares two groups one receiving TACE with drug-eluting beads loaded with doxorubicin plus nicardipine, and the other receiving TACE with beads loaded only with doxorubicin, which is the current standard of care. The beads deliver the chemotherapy directly to the tumor and block its blood supply, aiming to kill tumor cells. Nicardipine is included to inhibit the enzyme ABCB1, which cancer cells use to resist chemotherapy. The treatment involves injecting 1-3 mL of these beads into the liver artery feeding the tumor. Participants will be monitored for tumor response and survival over up to 12 months, with primary outcomes measured at 3 months including complete response rate and progression-free survival. Additional assessments include tumor markers, patient-reported outcomes, and overall survival. Safety and liver function will be closely followed. The trial starts in February 2026 and runs through June 2028, involving detailed imaging, laboratory tests, and clinical evaluations throughout the study period.

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