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Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres (IDASPHERE)

Primary Purpose

Localized Non-Resectable Adult Hepatocellular Carcinoma

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
blood samples (5 ml) will be taken
Chemoembolization
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Localized Non-Resectable Adult Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de DIJON

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

non-metastatic hepatocellular carcinoma

Arm Description

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 Biological : blood samples (5 ml) will be taken

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

Full Information

First Posted
August 12, 2016
Last Updated
August 18, 2016
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT02870010
Brief Title
Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres
Acronym
IDASPHERE
Official Title
Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres (DC Bead™) Loaded With Idarubicin (Zavedos®): Phase 1 Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Non-Resectable Adult Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-metastatic hepatocellular carcinoma
Arm Type
Experimental
Arm Description
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 Biological : blood samples (5 ml) will be taken
Intervention Type
Biological
Intervention Name(s)
blood samples (5 ml) will be taken
Intervention Description
blood samples (5 ml) will be taken
Intervention Type
Radiation
Intervention Name(s)
Chemoembolization
Intervention Description
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 Outcome Measure Information:
Title
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
Description
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).
Time Frame
total duration of participation for a patient: 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de DIJON
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

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

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