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    Summary
    EudraCT Number:2019-001362-15
    Sponsor's Protocol Code Number:7773
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-07-04
    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 number2019-001362-15
    A.3Full title of the trial
    Hepatocellular carcinoma less than 3 cm treated with percutaneous tumour destruction: multicentric phase 2 trial assessing the impact of idarubicin-lipiodol intra-arterial chemotherapy on hepatic recurrence.
    Carcinome hépatocellulaire de moins de 3 cm traité par destruction tumorale percutanée : essai de phase 2 multicentrique évaluant l'impact sur la récidive hépatique d'une chimiothérapie adjuvante par infusion intra-artérielle d'Idarubicine-Lipiodol.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hepatocellular carcinoma less than 3 cm treated with percutaneous tumour destruction: multicentric phase 2 trial assessing the impact of idarubicin-lipiodol intra-arterial chemotherapy on hepatic recurrence.
    Carcinome hépatocellulaire de moins de 3 cm traité par destruction tumorale percutanée : essai de phase 2 multicentrique évaluant l'impact sur la récidive hépatique d'une chimiothérapie adjuvante par infusion intra-artérielle d'Idarubicine-Lipiodol.
    A.3.2Name or abbreviated title of the trial where available
    LIDA-ADJ
    LIDA-ADJ
    A.4.1Sponsor's protocol code number7773
    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 Montpellier
    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 avenue Charles Flahault
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number0033467330814
    B.5.5Fax number0033467339172
    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 with idarubicin and lipiodol would be an effective adjuvant therapy of hepatocellular carcinoma
    L'hypothèse de la recherche est qu'un traitement locorégional hépatique par idarubicine et lipiodol serait une thérapie adjuvante efficace pour le traitement du carcinome hépatocellulaire
    E.1.1.1Medical condition in easily understood language
    The research hypothesis is that hepatic locoregional treatment with idarubicin and lipiodol would be an effective adjuvant therapy of hepatocellular carcinoma
    L'hypothèse de la recherche est qu'un traitement locorégional hépatique par idarubicine et lipiodol serait une thérapie adjuvante efficace pour le traitement du carcinome hépatocellulaire
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 compare the survival rate without hepatic tumour recurrence (local and/or intrahepatic distant) 1 year after percutaneous ablathermia of a less than 3 cm hepatocellular carcinoma with an adjuvant intra-arterial treatment by idarubicin - lipiodol versus the absence of adjuvant treatment.
    L’objectif principal est de comparer le taux de survie sans récidive tumorale hépatique (locale et/ou distante intra-hépatique) à 1 an après ablathermie percutanée d'un carcinome hépatocellulaire de moins de 3 cm après traitement adjuvant par chimiothérapie intra-artérielle d'Idarubicine -Lipiodol versus l’absence de traitement adjuvant.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare, after percutaneous ablathermy of a hepatocellular carcinoma of less than 3 cm, the impact of an adjuvant intra arterial treatment with idarubicin-lipiodol versus the absence of adjuvant treatment on :
    -the hepatic tumour recurrence (local + intrahepatic distant) at 2 years
    - the local tumor recurrence at 1 and 2 years
    - the intrahepatic recurrence at a distance from the percutaneous tumoral destruction site at 1 and 2 years
    - the survival without hepatic recurrence at 2 years
    - the global survival
    Les objectifs secondaires sont de comparer, après ablathermie percutanée d'un carcinome hépatocellulaire de moins de 3 cm, l'impact d'un traitement adjuvant par chimiothérapie intra-artérielle d'Idarubicine-Lipiodol versus l’absence de traitement adjuvant sur :

    -la récidive tumorale hépatique (locale + distante intra-hépatique) à 2 ans
    -la récidive tumorale locale à 1 et 2 ans
    -la récidive intra-hépatique à distance du site de DTP à 1 et 2 ans
    -la survie sans récidive hépatique à 2 ans
    -la survie globale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years and ≤ 80 years
    - Hepatopathy either histologically proven F3 or F4 stage, or with liver hardness measurements ≥10 kPa, either with suggestive morphological signs cirrhosis or portal hypertension viewed by medical Imaging
    - Child-Pugh score ≤B7
    - Patients with these biological parameters :
    • platelets > 50 000/mm3
    • neutrophils > 1000/mm3
    • TP > 50%
    • creatininemia < 150 µmol/L
    • total bilirubinemia < 5 mg/dL
    • α-fetoprotein < 200 ng/mL
    - WHO 0 or 1
    - unique and less than 3 cm hepatocellular carcinoma, with typical imaging characteristics as recommended by AASLD
    - patient with an indication of percutaneous tumoral destruction (radio frequency or microwave) under ultrasound or CT scan
    - Absence of heart failure (Left ventricular ejection fraction > 50%)
    - Woman of childbearing age using a method of contraception for the duration of treatment and at least 3 months after the end of treatment.
    - Man using a method of contraception for the duration of treatment and at least 3 months after the end of treatment.
    -Age ≥ 18 ans et ≤ 80 ans
    -Hépatopathie chronique soit histologiquement prouvée de stade F3 ou F4, soit avec mesures de dureté hépatique ≥ 10 kPa, soit avec des signes morphologiques en imagerie évocateurs de cirrhose ou hypertension portale
    -Score de Child-Pugh ≤B7
    -Patients dont les paramètres biologiques répondent aux critères suivant ;
    •Plaquettes > 50 000/mm3
    •Neutrophiles > 1 000/mm3
    •TP > 50%
    •Créatininémie < 150 µmol/L
    •Bilirubinémie totale < 5 mg/dL
    •α-fœtoprotéine < 200 ng/mL
    -Niveau de performance 0 ou 1 selon « World Health Organization Performance Status ».
    -Présence d'un carcinome hépatocellulaire de moins de 3 cm, unique, présentant des caractéristiques typiques en imagerie selon les recommandations de l'AASLD (Bruix J, Hepatology 2011)
    -Patient présentant une indication de DTP (radiofréquence ou micro-onde) sous repérage échographique ou tomodensitométrique.
    -Absence d’insuffisance cardiaque (FEVG échographique > 50%)
    -Femme en âge de procréer utilisant une méthode de contraception pendant toute la durée du traitement et au moins 3 mois après l'arrêt du traitement.
    -Homme utilisant une méthode de contraception pendant toute la durée du traitement et au moins 3 mois après l’arrêt du traitement.
    E.4Principal exclusion criteria
    - Pregnancy (determination of positive βHCG) or breastfeeding according to article L1121-5 of the CSP.
    - Presence on the initial imaging result of a macroscopic vascular invasion (portal or superhepatic vein).
    - Presence on the initial imaging result of non-hepatic locations of hepatocellular carcinoma.
    - Other non treated cancer
    - Contraindication to general anaesthesia
    - Contraindication to MRI Exploration
    - Hypersensitivity to anthracyclines, iodine or gadolinium.
    - Contraindication to injection of gadolinium-based contrast media
    - Contraindication to injection of iodine-based contrast media
    - Contraindication to idarubicin
    - Contraindication to Lipiodol
    - Patients who have already received or exceeded the recommended cumulative dose for anthracyclines (idarubicin = 150 mg/m²).
    - Failure of endoscopic elimination of esophageal varices with level >1.
    - Inability to accede to the protocol
    - Patient who for psychological, social, family or geographical reasons could not be followed regularly
    - Vulnerable persons according to Article L1121-6 of the CSP
    - Concurrent patient participation in another research involving the human person.
    - Non-affiliation with or no beneficiary of a social security scheme (Article L.1121-11).
    -Femme enceinte (dosage des βHCG positif) ou allaitante selon l’article L1121-5 du CSP.
    -Présence sur le bilan d'imagerie initial d'une invasion vasculaire macroscopique (veine porte ou sus-hépatique).
    -Présence sur le bilan d’imagerie initial de localisations extra-hépatiques du carcinome hépatocellulaire.
    -Deuxième cancer non traité
    -Contre-indication à la réalisation d'une anesthésie générale
    -Contre-indication à la réalisation d'une exploration par IRM (Pacemaker ou stimulateur neurosensoriel ou défibrillateur implantable, implants cochléaires, corps étrangers ferromagnétiques oculaires ou cérébraux proches des structures nerveuses, matériel d’injection automatisé implanté, prothèse métallique et tatouage contenant des particules de fer).
    -Allergie aux anthracyclines, à l'iode ou au gadolinium.
    -Contre-indication à l’injection de produits de contraste à base de sels de gadolinium (Antécédents d’hypersensibilité aux chélates de gadolinium, à la méglumine, insuffisance rénale aigüe avec un DFG<30ml/min ou causée par un syndrome hépato-rénal ou pendant la période péri-opératoire d'une transplantation rénale).
    -Contre-indication aux produits de contraste iodé (Thyréotoxicose manifeste, hypersensibilité à la substance active ou à l'un des excipients, antécédents de réaction immédiate majeure ou cutanée retardée, asthme bronchique),
    -Contre-indications à l’Idarubicine (hypersensibilité à la substance active ou aux excipients, arythmie sévère, insuffisance rénale ou hépatique grave, vaccin anti-amarile (fièvre jaune) ou tout autre vaccin vivant atténué et ce pendant 6 mois suivant l'arrêt de la chimiothérapie, myélosupression persistante, traitements antérieurs par idarubicine et/ou d’autres anthracyclines ou anthracénediones aux doses maximales cumulatives, stomatite, infections non contrôlées, insuffisance cardiaque sévère, infarctus du myocarde de moins de 6 mois).
    -Contre-indication au Lipiodol (Hypersensibilité, Hyperthyroïdie avérée, lésions traumatiques, hémorragies ou saignements récents, bronchographie).
    -Patients ayant déjà reçu ou dépassé la dose cumulative recommandée pour les anthracyclines (Idarubicine= 150 mg/m²).
    -Echec d’éradication endoscopique des varices œsophagiennes de grade >1.
    -Incapacité à adhérer au protocole
    -Patient qui pour des raisons psychologiques, sociales, familiales ou géographiques ne pourrait pas être suivi régulièrement
    -Personnes vulnérables selon l’article L1121-6 du CSP
    -Participation concomitante du patient à une autre recherche impliquant la personne humaine.
    -Non affiliation à un régime de sécurité sociale ou bénéficiaire d’un tel régime (article L.1121-11).
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the survival rate without hepatic recurrence (local and/or intrahepatic) at 1 year.
    Le critère de jugement principal est le taux de survie sans récidive hépatique (locale et/ou intra-hépatique distante) à 1 an.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At one year after the treatment
    1 an après le traitement
    E.5.2Secondary end point(s)
    The secondary end points are :
    • Accumulated rate of local hepatic recurrence at 1 and 2 years
    • Accumulated rate of distant intrahepatic recurrence at 1 and 2 years
    • Accumulated rate of hepatic recurrence (local and/or distant intrahepatic) at 1 and 2 years
    • Survival without hepatic recurrence in months between the randomization date and the date of hepatic MRI confirming hepatic recurrence
    • Survival rate without hepatic recurrence (local and/or distant intrahepatic) at 2 years
    • Overall survival in months from the randomization date to the date of the death of patient
    Les critères de jugement secondaires sont :

    •Le taux cumulé de récidive hépatique locale à 1 et 2 ans
    •Le taux cumulé de récidive intra-hépatique distante à 1 et 2 ans
    •Le taux cumulé de récidive hépatique (locale et/ou intra-hépatique distante) à 1 et 2 ans
    •La survie sans récidive hépatique en mois entre la date de randomisation et la date de l'IRM hépatique confirmant la présence d'une récidive tumorale hépatique
    •Le taux de survie sans récidive hépatique (locale et/ou intra-hépatique distante) à 2 ans
    •La survie globale en mois entre la date de randomisation et la date de décès du patient
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 1 and/or 2 years after the treatment
    1 et/ou 2 ans après le traitement
    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 No
    E.6.5Efficacy No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    destruction tumorale percutanée seulement
    percutaneous tumoral destruction only
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months43
    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 state138
    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 Decision2019-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-07-14
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