MedTrace Logo

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

NCT02028949 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-02-09

No results posted yet for this study

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

DRUG

Zavedos®

OTHER

Blood samples

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-22
Primary Completion
2015-11-30
Completion
2016-02-05

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028949 on ClinicalTrials.gov