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    Summary
    EudraCT Number:2017-004859-22
    Sponsor's Protocol Code Number:UF9888
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-04-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2017-004859-22
    A.3Full title of the trial
    Treatment of hepatocellular carcinoma on child cirrhosis A/B7 by intra-arterial injection of a Lipiodol and Idarubicin emulsion : a multicentric single-arm phase II study
    Traitement des carcinomes hepatocellulaires sur cirrhose child a/b7 par injection intra-arterielle d’une emulsion de lipiodol et idarubicine : etude de phase II monobras, multicentrique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy and tolerance of a chemotherapy by Idarubicin and Lipiodol emulsion administer in the liver, by the hepatic artery, on hepatocellular carcinoma.
    Evaluation de l'efficacité et de la tolérance d'une chimiothérapie par Idarubicin et Lipiodol administrée dans le foie, par l'artère hépatique, sur les carcinomes hépatocellulaires.
    A.3.2Name or abbreviated title of the trial where available
    LIDA-BII
    LIDA-BII
    A.4.1Sponsor's protocol code numberUF9888
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospital of Monptellier
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Hospital of Montpellier
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Montpellier
    B.5.2Functional name of contact pointCadène Anne
    B.5.3 Address:
    B.5.3.1Street AddressDRI, Pav 32-39 aenue Charles Flahault
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number003346330814
    B.5.5Fax number003346339172
    B.5.6E-maila-cadene@chu-montpellier.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Zavedos (Idarubicin)
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrahepatic use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name LIPIODOL
    D.2.1.1.2Name of the Marketing Authorisation holderGuerbet
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrahepatic use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The research hypothesis is that hepatic locoregional treatment without embolization, using a more cytotoxic anticancer molecule (Idarubicin) than those conventionally used, would be more effective.
    L’hypothèse de la recherche est qu’un traitement locorégional hépatique sans embolisation en utilisant une molécule anticancéreuse plus cytotoxique (Idarubicine) que celles classiquement utilisées serait plus efficace.
    E.1.1.1Medical condition in easily understood language
    The research hypothesis is that hepatic locoregional treatment without embolization, using a more cytotoxic anticancer molecule than those conventionally used, would be more effective.
    L’hypothèse est qu’un traitement locorégional hépatique sans embolisation en utilisant une molécule anticancéreuse plus cytotoxique que celles classiquement utilisées serait plus efficace.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate the disease control rate (complete response, partial or stabilization) 4 months from the date of the first cycle of chemotherapy-lipiodol according to the criteria mRECIST.
    L’objectif principal est d’évaluer le taux de contrôle de la maladie (réponse complète, partielle ou stabilisation) 4 mois à compter de la date de la 1ère cure de chimiothérapie-lipiodol selon les critères mRECIST.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate:
     The time until treatment fails,
     Progression-free survival
     The objective response rate at 6 months from the date of the first chemotherapy-lipiodol cycle,
     The tolerance of the treatment,
     Overall survival at 12 months from the date of the first cycle of chemotherapy-lipiodol,
     The quality of life at 12 months from the date of the first chemotherapy treatment-lipiodol,
     The rate of thrombosis / hepatic arterial stenosis after each course of chemo-Lipiodol.
    Les objectifs secondaires sont d’évaluer :
     Le temps jusqu’à échec du traitement,
     La survie sans progression,
     Le taux de réponse objective à 6 mois à compter de la date de la 1ère cure de chimiothérapie-lipiodol,
     La tolérance du traitement,
     La survie globale à 12 mois à compter de la date de la 1ère cure de chimiothérapie-lipiodol,
     La qualité de vie à 12 mois à compter de la date de la 1ère cure de chimiothérapie-lipiodol,
     Le taux de thrombose/sténose artérielle hépatique après chaque cure de chimio-Lipiodol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically proven hepatocellular carcinoma (or according to EASL criteria)
    • Child-Pugh A or B7 cirrhosis
    • Tumor not accessible to surgical resection, percutaneous ablation or radiofrequency
    • WHO 0 or 1
    • BCLC A / B or C if WHO = 1
    • Targets measurable according to mRECIST criteria v1.1
    • No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation
    • Age ≥ 18 years
    • Carcinome Hépatocellulaire histologiquement prouvé ou selon les critères EASL
    • Cirrhose Child-Pugh A ou B7
    • Tumeur non accessible à une résection chirurgicale, à une ablation percutanée ou à une radiofréquence
    • OMS 0 ou 1
    • BCLC A/B ou C si OMS = 1
    • Cibles mesurables selon les critères mRECIST v1.1
    • Pas de traitement préalable par chimiothérapie, radiothérapie ou embolisation transartérielle (avec ou sans chimiothérapie) ou radioembolisation
    • Age ≥ 18 ans
    E.4Principal exclusion criteria
    • Advanced tumor disease
    • Diffuse hepatocellular carcinoma with liver invasion> 50%
    • Past cancers history excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ adequately treated with curative intent
    • Advanced liver disease (Child B8, B9 and C)
    • Contraindication to performing a liver MRI
    • Contraindication to the injection of gadolinium-based contrast media
    • Contraindication to Idarubicin
    • Contraindication to Lipiodol
    • Vascular anatomy makes it impossible to perform intra-arterial liver treatments
    • Ligation or sizing of gastroesophageal varices for less than a month.
    • Pregnancy (determination of positive βHCG) or breastfeeding according to article L1121-5 of the CSP.
    • Maladie tumorale avancée
    • Carcinome Hépatocellulaire diffus avec un envahissement du foie > 50%
    • Antécédent d’autre cancer à l’exclusion de cancers reconnus comme guéris depuis plus de 5 ans ou de tumeurs cutanées basocellulaires ou du cancer du col de l’utérus in situ traités de façon adéquate et à visée curative
    • Maladie du foie avancée (Child B8, B9 et C)
    • Contre-indication à la réalisation d’une IRM hépatique
    • Contre-indication à l’injection de produits de contraste à base de sels de gadolinium
    • Contre-indications à l’Idarubicine
    • Contre-indication au Lipiodol
    • Anatomie vasculaire qui rend impossible la réalisation de traitements intra-artériels hépatiques
    • Ligature ou encollage de varices œsogastriques depuis moins d’un mois.
    • Grossesse (dosage des βHCG positif) ou allaitement selon l’article L1121-5 du CSP.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percentage of patients with disease control (complete, partial or stabilized response) 4 months from the date of the first chemo-lipiodol cycle according to mRECIST criteria.
    Le critère d’évaluation principal est le pourcentage de patients présentant un contrôle de la maladie (réponse complète, partielle ou stabilisation) 4 mois à compter de la date de la 1ère cure de chimiothérapie-lipiodol selon les critères mRECIST
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 months after the first cycle of chemo-lipiodol
    4 mois après la date de la première cure de chimio-lipiodol
    E.5.2Secondary end point(s)
    Secondary endpoints will be:
     Time to treatment failure defined between the inclusion date and the date of treatment failure or the date of the latest news.
     Progression-free survival defined as the time between the date of inclusion and the date of first radiological progression or death (whichever comes first) or the date of last new.
     The objective response rate (complete response or partial response) at 6 months from the date of the first chemo-lipiodol treatment according to the mRECIST criteria evaluated according to the investigator and centralized re-reading.
     The tolerance defined according to the NCI-CTC AE scale (version 4.03 published on June 14, 2010)
     Overall survival defined as the time between the date of inclusion and the date of death or the date of last news.
     The quality of life evaluated using the QLQ-C30 specific questionnaire of the European Organization for Research and Treatment of Cancer (EORTC).
     The rate of thrombosis / hepatic arterial stenosis defined as the number of cycle during which vascular thrombosis or stenosis are visible on the initial arteriogram of the hepatic artery, divided by the total number of cures.
    Les critères d’évaluation secondaires sont :
     Temps jusqu’à échec du traitement défini comme l’intervalle de temps entre la date d’inclusion et la date d’échec du traitement ou la date des dernières nouvelles.
     La survie sans progression définie comme le temps entre la date d’inclusion et la date de première progression radiologique ou le décès (selon la première éventualité) ou la date de dernière nouvelle.
     Le taux de patients en réponse objective (réponse complète ou réponse partielle) à 6 mois à compter de la date de la 1ère cure de chimiothérapie-lipiodol selon les critères mRECIST évalué selon l’investigateur et en relecture centralisée.
     La tolérance définie selon l’échelle NCI-CTC AE (version 4.03 publié le 14 juin 2010)
     La survie globale définie comme le temps entre la date d’inclusion et la date de décès ou la date de dernière nouvelle.
     La qualité de vie évaluée à l’aide du questionnaire spécifique QLQ-C30 de l’European Organisation for Research and Treatment of Cancer (EORTC).
     Le taux de thrombose/sténose artérielle hépatique défini comme le nombre de cures durant laquelle une thrombose vasculaire ou une sténose est/sont visible(s) sur l’artériographie initiale de(s) artère(s) hépatique(s), divisé par le nombre total de cures.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 months after the first cycle of chemo-lipiodol
    4 moi après la date de la première cure de chimio-lipiodol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state53
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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