Completed

NCT Number: NCT02028949

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

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.

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Key information

Conditions

Unresectable Non-metastatic Hepatocellular Carcinoma Child A/B7 Cirrhosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de Dijon

Dijon, 21079 Cedex, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histologically-proven hepatocellular carcinoma or carcinoma meeting validated non-invasive criteria (EASL, AASLD)

Child-Pugh A OR B7 cirrhosis
General health status WHO 0.1
Platelets > 50 000/mm3, Polynuclear neutrophils > 1000/mm3
Creatininemia < 1.5 times upper limit of normal
LVEF by MUGA scan or US > 50 %
Age > 18 years
Signed informed consent
For women child-bearing age, an effective means of contraception

Exclusion criteria

Patients who can benefit from curative treatment (surgical resection, liver transplant or treatment via percutaneous destruction)

Non-cirrhotic liver
Cirrhosis Child B8 or B9 or C
Extrahepatic metastases (pulmonary micronodules < 7mm are not considered a contra-indication)
Digestive hemorrhage within the previous month
Patient on anticoagulants
Pregnant women
Uncontrolled infection
Hypersensitivity to anthracyclines
Hypersensitivity to iodine contrast agents
Patient under guardianship or ward of court
Patients who have already received the recommended cumulative dose of anthracycline (93 mg/m2 for idarubicin, 140 mg/m2 for mitoxantrone, 550 mg/m2 for doxorubicin, 600 mg/m2 for daunorubicin, 900 mg/m2 for epirubicin)

Treatment and study plan

Zavedos®

Drug

Blood Samples

Other

Primary outcomes

tolerance: toxicity will be evaluated according to the NCI CTC AE version 4.03 scale to determine the limiting dose

Time frame: 7 weeks after the 2 injections

Secondary outcomes

Study the pharmacokinetics of idarubicin in this delivery method

Time frame: 24 months
Evaluate overall survival

Time frame: 24 months
Evaluate progression-free survival

Time frame: 24 months
Evaluate time to progression

Time frame: 24 months
Evaluate the rate of objective response

Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2016
First posted: Jan 7, 2014
Registry last updated: Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.