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Unresectable Non-metastatic Hepatocellular CarcinomaPhase 1NCT02028949

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

A Phase 1 study testing Zavedos® and Blood samples in people with Unresectable Non-metastatic Hepatocellular Carcinoma and Child A/B7 Cirrhosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zavedos® and Blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteFrance
Study dates
22 Nov 2012to 5 Feb 2016
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
  • Adult, Older adult

Who may be able to join

  • 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 %
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  • Age > 18 years
  • Signed informed consent
  • For women child-bearing age, an effective means of contraception

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Dijon

    Dijon, 21079 Cedex

Other trials in France

About this study

Official title: 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.
Being tested
Zavedos®, Blood samples

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zavedos®Drug

  • Blood samplesOther

Study groups in NCT02028949
Study groupRoleWhat they receive
Chemo-lipiodolExperimentalNot described
Receives: Drug: Zavedos®; Other: Blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. tolerance: toxicity will be evaluated according to the NCI CTC AE version 4.03 scale to determine the limiting dose

    Measured: 7 weeks after the 2 injections

Secondary outcomes (5)

  1. Study the pharmacokinetics of idarubicin in this delivery method

    Measured: 24 months

  2. Evaluate overall survival

    Measured: 24 months

  3. Evaluate progression-free survival

    Measured: 24 months

  4. Evaluate time to progression

    Measured: 24 months

  5. Evaluate the rate of objective response

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2014 (estimated)
  2. Study start22 Nov 2012
  3. Primary completionNov 2015
  4. Study completion5 Feb 2016

Resources

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
Allocation
Non-randomised
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02028949
Sponsor's protocol ID
GUIU APJ 2012
Status last verified
Feb 2026
First submitted
18 Dec 2013
Last updated
9 Feb 2026
Results posted
No

Publications

  • Guiu B, Jouve JL, Schmitt A, Minello A, Bonnetain F, Cassinotto C, Piron L, Cercueil JP, Loffroy R, Latournerie M, Wendremaire M, Lepage C, Boulin M. Intra-arterial idarubicin_lipiodol without embolisation in hepatocellular carcinoma: The LIDA-B phase I trial. J Hepatol. 2018 Jun;68(6):1163-1171. doi: 10.1016/j.jhep.2018.01.022. Epub 2018 Feb 8.

    PubMed 29427728

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zavedos® and Blood samples in people with Unresectable Non-metastatic Hepatocellular Carcinoma and Child A/B7 Cirrhosis, 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 9 inclusion and 12 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 9 Feb 2026. 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: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02028949, which also lists 1 linked publication.

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 9 Feb 2026.

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