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Completed

NCT Number: NCT02870010

Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres

Chemoembolization is a recognized treatment strategy for hepatocellular carcinoma (HCC)

* classical chemoembolization consists in injecting an emulsion of an anticancer agent in Lipiodol® via the hepatic artery * doxorubicin, an anthracycline, is the most frequently used drug in lipiodol chemoembolization (LCE) * however, less than half of HCC respond favourably to classical lipiodol chemoembolization (LCE) with doxorubicin/Lipiodol®

In this trial, we propose to introduce in clinical practice a strategy based on idarubicin to achieve a more effective antitumor effect for the following reasons, recently pointed out by our team:

* idarubicin is an anthracycline that penetrates tumour cells more quickly and is more cytotoxic than doxorubicin on hepatocellular carcinoma cell lines * idarubicin is injected in a solution of embolization microspheres of a diameter of (300-500µm), which all the progressive and controlled release of the anticancer drug, whereas the doxorubicin/Lipiodol® emulsion is unstable

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Key information

Conditions

Localized Non-Resectable Adult Hepatocellular Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de DIJON

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-

Hepatocellular carcinoma(HCC) proven by cytology or histology or diagnosis according to the 2005 criteria of the American Association for the Study of Liver Diseases, (AASLD), which requires the presence of histological or unequivocal cirhosis and according to the size of nodules:

  • nodule < 1 cm: increase in the size according to US scan every 3-4 months
  • nodule between 1 and 2 cm: 2 concordant imaging techniques: CT-scan, MRI, contrast-enhanced US (CEUS); diagnosis of Hepatocellular carcinoma (HCC) in the presence of typical images (hypervascularized arterial + wash-out phase) with 2 imaging methods; in other cases, biopsy.
  • nodule > 2 cm: CT-scan or MRI or CEUS (only 1 technique); diagnosis of Hepatocellular carcinoma (HCC) in the presence of hypervascularization associated with either a wash-out image or alphafoetoprotein> 200 µg/L; in other cases, biopsy.
  • A maximum of 3 nodules (Single-lobe disease - no limit to the number of nodules, in bilobar disease - a maximum of 3 nodules) distributed throughout the liver and detected by liver MRI with the injection of Gadolinium chelate, dating back less than 1 month. In cases of a contra-indication for MRI (pacemaker, metallic intra-ocular foreign body, certains cardiac valves et certains intra-cranial clips), a CT-scan with and without iodine-based contrast).
  • cases of cirrhosis: Child-Pugh stage A or B 7 without ascites, or icterus
  • WHO perfomance status 0, 1
  • Platelets > 50 000/mm3, Polynuclear neutrophils > 1000/mm3
  • Creatininemia < 150 µmol/l
  • Absence of heart failure (isotopic or US LVEF > 50%)
  • Age >18 years
  • Written informed consent

Exclusion criteria

  • Patients able to undergo surgical resection or liver transplantation or local treatment with radio-frequency ablation
  • Extra-hepatic metastases (lungs, bones, peritoneum...)
  • Digestive haemorrhage dating back less than one month
  • Patients on anticoagulants
  • Portal thrombosis occurring in more than one segmental branch or hepatofugal flow on the Doppler
  • Pregnant women
  • Uncontrolled infection
  • Hypersensitivity to anthracyclines
  • Hypersensitivity to iodine contrast agents
  • Patients under guardianship

Treatment and study plan

blood samples (5 ml) will be taken

Biological

blood samples (5 ml) will be taken

Chemoembolization

Radiation

Chemoembolization will take place in the Interventional Radiology room: the syringe, prepared at the pharmacy, will contain microspheres loaded with a defined dose of idarubicin. Then five millilitres of Visipaque® will be added to visualize the injection

Primary outcomes

  1. Tolerance: toxicities will be defined according to the scale: National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTC AE v3.0) to determine the limiting dose

    Time frame: total duration of participation for a patient: 2 months

    Patients will be hospitalized for 3 days starting from the date of the chemoembolization and will then be followed regularly for 2 months from the date of the chemoembolization (clinical, biological and radiological surveillance).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres (DC Bead™) Loaded With Idarubicin (Zavedos®): Phase 1 Study

Acronym: IDASPHERE

Important dates

Study start
2010
Primary completion
2012
First posted
Aug 17, 2016
Registry last updated
Aug 19, 2016

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.

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