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Carcinoma, HepatocellularPhase 2LIDA-BIINCT03727633

Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion

A Phase 2 study testing Idarubicin and Lipiodol in people with Carcinoma, Hepatocellular, run by University Hospital, Montpellier at 4 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The investigators propose in this trial to test a hepatic chemotherapy, consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol, lipid vector, without embolization in the treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Idarubicin and Lipiodol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
4 sitesFrance
Study dates
19 Jul 2018to 3 Jan 2026
Phase
Phase 2
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

  • Histologically-proven HCC or according to EASL criteria
  • Child-Pugh A or B7
  • Disease that is not suitable for resection, ablation or radiofrequency
  • Performance Status ECOG 0 or 1
  • BCLC A/B or C if Performance Status ECOG = 1
  • Measurable lesions according to mRECIST criteria
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  • No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation
  • Age superior or equal to 18 years
  • Platelets > 50,000/mm3, Polynuclear neutrophils > 1000/mm3, Creatininemia < 150umol/L, Bilirubinemia < 5 mg/dL
  • Absence of heart failure (Ultrasound LVEF > 50%)
  • Women of child-bearing age using an adequate method of contraception throughout treatment
  • Men using an adequate method of contraception throughout the treatment and at least 3 months after the end of treatment
  • Written informed consent
  • National health insurance cover

Who cannot join

  • Advanced tumor disease (extrahepatic except pulmonary micronodules <7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.)
  • Large HCC with liver invasion >50%
  • History of other cancer than HCC and excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ treated with adequate and curative purpose
  • Advanced liver disease (Child B8, B9 or C)
  • Contra-indication for the MRI (Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreing body similar to the nervous structure)
  • Contra-indication to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine).
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  • Contra-indication to idarubicin (Hypersensibility to active substance or excipients, cardiopathy with myocardial insufficiency of less than 6 months, serious arrhythmias, serious renal or liver failure, yellow fever vaccine or any other live attenuated vaccine, persistente myelosuppression, previous treatments with idarubicin and/or other anthracyclines or anthracenediones at maximum cumulative doses, stomatitis)
  • Contra-indication to Lipiodol (Hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding)
  • Concomitant disease or uncontrolled severe clinical situation
  • Uncontrolled severe infection
  • Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments
  • Pregnancy (Beta HCG positive) or breastfeeding
  • Patient who for psychological, social, family or geographical reasons cannot be followed regularly
  • Vulnerable person
  • Concomitant participation of the patient in another research involving the human person

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CHU d'Angers

    Angers, 49933

  • CHU de Dijon

    Dijon, 21079

  • CHU de Montpellier

    Montpellier, 34295

  • CHU de Nice

    Nice, 06202

Other trials in France

About this study

Official title: Traitement Des Carcinomes hépatocellulaires Sur Cirrhose Child A/B7 Par Injection Intra-artérielle hépatique d'Une émulsion de Lipiodol et Idarubicine : Etude de Phase II, Monobras, Multicentrique.

The investigators propose in this trial to test a hepatic chemotherapy, consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol, lipid vector, without embolization in the treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.

Being tested
Idarubicin and Lipiodol
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Idarubicin and LipiodolDrug

    Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol

Study groups in NCT03727633
Study groupRoleWhat they receive
Treatment armExperimentalhepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol
Receives: Drug: Idarubicin and Lipiodol

What is being measured

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

  1. Percentage of participants presenting a disease control at 4 months

    The primary outcome is to evaluate the disease control rate (partial, complete or stable response) 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.

    Measured: 4 months

Secondary outcomes (5)

  1. Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03

    Safety defined by NCI-CTCAE version 4.03 published 14 june 2010

    Measured: 12 months

  2. Objective response rate of chemo-lipiodol

    Objective response rate according to mRECIST at 6 months after the first cycle

    Measured: 6 months

  3. best response at 6 months after the first cycle of chemo-lipiodol according to mRECIST

    The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol

    Measured: 6 months

  4. Overall survival

    Overall survival at 12 months after the first cycle of chemo-lipiodol

    Measured: 12 months

  5. Quality of life questionnaire (QLQ) QLQ-C30

    Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol (QLQ-C30). Subscale minimum score is egal to 1 (not at all) and maximum score is egal to 4 (very much). The maximal score correspond to a better quality of life. Subscales are summed to compute a total score.

    Measured: 12 months

Timeline

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

  1. First posted1 Nov 2018
  2. Study start19 Jul 2018
  3. Primary completion18 Jun 2025
  4. Study completion3 Jan 2026

Why it stopped: Enrollement rythm low, funding body decision.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The purpose of this study is to assess efficacy and tolerance of hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol for treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03727633
Sponsor's protocol ID
RECHMPL17_0304
Other IDs
2017-004859-22, UF 9888, 2017
Acronym
LIDA-BII
Status last verified
Mar 2026
First submitted
31 May 2018
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Idarubicin and Lipiodol in people with Carcinoma, Hepatocellular, run by University Hospital, Montpellier at 4 sites 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 14 inclusion and 15 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: stopped early, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Enrollement rythm low, funding body decision.). Results are not available in the source record.

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?

Percentage of participants presenting a disease control at 4 months (time frame: 4 months). 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 NCT03727633.

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 31 Mar 2026.

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