Localized Non-Resectable Adult Hepatocellular CarcinomaPhase 1IDASPHERENCT02870010
Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres
A Phase 1 study testing blood samples (5 ml) will be taken and Chemoembolization in people with Localized Non-Resectable Adult Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Localized Non-Resectable Adult Hepatocellular Carcinoma
- What is being tested?
- blood samples (5 ml) will be taken and Chemoembolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 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).
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- 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
Who cannot join
- 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
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- Uncontrolled infection
- Hypersensitivity to anthracyclines
- Hypersensitivity to iodine contrast agents
- Patients under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres (DC Bead™) Loaded With Idarubicin (Zavedos®): Phase 1 Study
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®
Read more
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
- Being tested
- blood samples (5 ml) will be taken, Chemoembolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samples (5 ml) will be takenBiological
blood samples (5 ml) will be taken
ChemoembolizationRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| non-metastatic hepatocellular carcinoma | Experimental | * 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 Receives: Biological: blood samples (5 ml) will be taken; Radiation: Chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: total duration of participation for a patient: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startFeb 2010
- Primary completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Non-Resectable Adult Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870010
- Sponsor's protocol ID
- Boulin AOI 2009
- Acronym
- IDASPHERE
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres (DC Bead™) Loaded With Idarubicin (Zavedos®): Phase 1 Study
- ClinicalTrials.gov ID
- NCT02870010
- Acronym / sponsor ID
- IDASPHERE / Boulin AOI 2009
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2012 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-metastatic hepatocellular carcinoma | Experimental | Biological: blood samples (5 ml) will be taken, Radiation: 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 * Biological : blood samples (5 ml) will be taken |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- -
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples (5 ml) will be takenblood samples (5 ml) will be taken | Biological | non-metastatic hepatocellular carcinoma |
| ChemoembolizationChemoembolization 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 | Radiation | non-metastatic hepatocellular carcinoma |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing blood samples (5 ml) will be taken and Chemoembolization in people with Localized Non-Resectable Adult Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.