NCT02028949

Treatment of Cirrhosis-related Hepatocellular Carcinoma With the Intrahepatic Arterial Injection of an Emulsion of Lipiodol and Idarubicin (Zavedos®): Phase I Study

LIDA-B: Treatment of Cirrhosis-related Hepatocellular Carcinoma With the Intrahepatic Arterial Injection of an Emulsion of Lipiodol and Idarubicin (Zavedos®): Phase I Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Unresectable, non-metastatic cirrhosis-related hepatocellular carcinoma (HCC) has a poor prognosis as there are no recommended curative treatments. Chemoembolisation is the most widely used treatment in these patients, but this technique can prove to be toxic. intrahepatic arterial chemotherapy with lipiodol and idarubicin could be an effective therapeutic approach, without deteriorating liver function. The rationale for this treatment can be resumed as follows: * HCC are vascularised via the hepatic artery system * The IHA perfusion of anthracyclines leads to high elimination via the liver with low systemic concentrations * The absence of embolisation reduces toxicity * the toxiciity profile of idarubicin is well known and the drug is widely used for the IV treatment of leukemia * idarubicin is the most cytotoxic drug for tumor cell lines. * The in vitro cytotoxicity of idarubicin is 100% at low concentrations * Lipiodol can stay in contact with tumor tissue for several weeks after injection and act as a vector for the drug * The idarubicin-lipiodol is more stable than lipidol emulsions usually given by intraarterial injection * The emulsion is more stable with idarubicin than with other anticancer molecules * Sequential inclusion in accordance with the "continual reassessment method" makes it possible to increase inclusions at a target toxicity level while reducing inclusions at doses that are too low or too toxic The aim of the treatment is to improve survival.

Conditions

• Unresectable Non-metastatic Hepatocellular Carcinoma
• Child A/B7 Cirrhosis

Interventions

Type	Name	Description
DRUG	Zavedos®
OTHER	Blood samples

Timeline

• Start date: 2012-11-22
• Primary completion: 2015-11-01
• Completion: 2016-02-05
• First posted: 2014-01-07
• Last updated: 2026-02-09

Locations

1 site across 1 country: France