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

February 5, 2026 updated by: Centre Hospitalier Universitaire Dijon

LIDA-B: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079 Cedex
        • CHU de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemo-lipiodol
Other: Blood samples
Drug: Zavedos®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 weeks after the 2 injections

Secondary Outcome Measures

Outcome Measure
Time Frame
Study the pharmacokinetics of idarubicin in this delivery method
Time Frame: 24 months
24 months
Evaluate overall survival
Time Frame: 24 months
24 months
Evaluate progression-free survival
Time Frame: 24 months
24 months
Evaluate time to progression
Time Frame: 24 months
24 months
Evaluate the rate of objective response
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

February 5, 2016

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimated)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUIU APJ 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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