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

Phase 1

Completed

• Conditions: Unresectable Non-metastatic Hepatocellular Carcinoma; Child A/B7 Cirrhosis
• Interventions: Drug: Zavedos®; Other: Blood samples

• Registration Number: NCT02028949
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-22
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Primary Completion: 2015-11
• Study Completion: 2016-02-05
• Status Verified: 2017-04
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chemo-lipiodol	Zavedos®	-
Chemo-lipiodol	Blood samples	-

Primary Outcome Measures

Name	Time	Method
tolerance: toxicity will be evaluated according to the NCI CTC AE version 4.03 scale to determine the limiting dose	7 weeks after the 2 injections

Secondary Outcome Measures

Name	Time	Method
Study the pharmacokinetics of idarubicin in this delivery method	24 months
Evaluate overall survival	24 months
Evaluate time to progression	24 months
Evaluate the rate of objective response	24 months
Evaluate progression-free survival	24 months

Trial Locations

Locations (1)

CHU de Dijon; 🇫🇷 Dijon, France