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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-001575-16
    Sponsor's Protocol Code Number:2017-02-32-005
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-02
    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 number2021-001575-16
    A.3Full title of the trial
    A multicenter open-label randomized controlled prospective phase II study evaluating the efficacy of Selective Internal Radiation Therapy (Yttrium-90 glass microspheres) combined with Capecitabine in the neoadjuvant setting of Operable intrahepatic CHOlangiocarcinoma
    Etude prospective de phase II, multicentrique, randomisée en ouvert, évaluant l’efficacité de la Radiothérapie Interne Sélective (Microsphères de verre marquées à l’Yttrium-90) associée à la Capecitabine en néoadjuvant dans le traitement du CHOlangiocarcinome intra-hépatique Opérable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Selective Internal Radiation Therapy and Capecitabine (chemotherapy) treatment for liver cancer
    Traitement par Radiothérapie Interne Sélective et Capecitabine (chimiothérapie) dans le cancer du foie
    A.3.2Name or abbreviated title of the trial where available
    S7-PRODIGE-SIROCHO
    S7-PRODIGE-SIROCHO
    A.4.1Sponsor's protocol code number2017-02-32-005
    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 SponsorCentre Régional de lutte contre le Cancer Eugène Marquis
    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 supportBoston Scientific Corporation
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportCentre Régional de lutte contre le cancer Eugène Marquis
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Régional de lutte contre le cancer Eugène Marquis
    B.5.2Functional name of contact pointCellule Promotion de la DRC
    B.5.3 Address:
    B.5.3.1Street AddressAvenue de la Bataille Flandres-Dunkerque
    B.5.3.2Town/ cityRENNES
    B.5.3.3Post code35042
    B.5.3.4CountryFrance
    B.5.4Telephone number330299253165
    B.5.5Fax number330299253234
    B.5.6E-mailpromotion@rennes.unicancer.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 CAPECITABINE ACCORD
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE
    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.3.1Product nameCAPECITABINE ACCORD
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 THERASPHERE
    D.2.1.1.2Name of the Marketing Authorisation holderBoston Scientific
    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.3.1Product nameTHERASPHERE
    D.3.4Pharmaceutical form Radiopharmaceutical precursor, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    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 Yes
    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
    Patients having operable intrahepatic cholangiocarcinoma
    Patients présentant un cholangiocarcinome intra-hépatique résécable
    E.1.1.1Medical condition in easily understood language
    Biliary tract cancer
    Cancer des voies biliaires
    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 10073077
    E.1.2Term Intrahepatic cholangiocarcinoma
    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
    To assess efficacy of the combination of neoadjuvant SIRT and capecitabine in neoadjuvant setting of patients with a resectable cholangiocarcinoma
    Evaluer l’efficacité de l’association de la SIRT et de la capecitabine en situation néoadjuvante dans le cadre du traitement des patients atteints d’un cholangiocarcinome résécable
    E.2.2Secondary objectives of the trial
    To assess the safety of the neoadjuvant combination of SIRT and capecitabine
    To assess the quality of life related to health of the patients treated by the combination of SIRT and capecitabine
    Evaluer la sécurité de la combinaison néoadjuvante de la SIRT et de la capecitabine
    Evaluer la qualité de vie des patients traités par la combinaison néoadjuvante de la SIRT et de la capecitabine
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Circulating biomarkers : to evaluate the prognostic value of circular RNAs in patients treated with SIRT for ICC, to evaluate the evolution of circRNAs following treatment and to evaluate circRNAs has potential biomarker of recurrence.
    Biomarqueurs circulants : évaluer la valeur pronostique des ARN circulaires chez les patients traités par SIRT pour ICC, évaluer l'évolution des ARN circulaires après le traitement et évaluer les ARN circulaires comme biomarqueurs potentiels de récidive.
    E.3Principal inclusion criteria
    Age > 18 years-old,
    ECOG Performance Status <2
    Histologically-proven ICC
    No previous treatment,
    Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board,
    Significant risk of close margins, defined as:
    - Resection margin predicted by the surgeon <1cm
    - Tumour > 5cm
    - Multifocal lesion deemed resectable, validated by a Surgical Review Board
    Patient information and signature of informed consent or legal representative.
    Âge ≥ 18 ans,
    Performance Status ECOG < 2,
    CCIH prouvé histologiquement,
    Pas de traitement préalable,
    Tumeur réputée résécable par un chirurgien hépatobiliaire, validé par un comité d’examen chirurgical,
    Risque important d’atteinte des marges, défini comme :
    - Marge de résection prédite par le chirurgien < 1 cm
    - Tumeur > 5 cm
    - Lésion multifocale réputée résécable, validée par un comité de revue chirurgical
    Information du patient et signature du consentement éclairé ou de son représentant légal.
    E.4Principal exclusion criteria
    Cirrhosis,
    Inadequate haematological, hepatic, renal and coagulation functions:
    - Haemoglobin ≤ 8,5 g/dl
    - Neutrophils < 1,5 Giga/L
    - Platelets < 60 Giga/L
    - Bilirubin > 34 µmol/L
    - ASAT/ALAT > 5 x ULN
    - Creatinine clearance < 30 ml/min (MDRD)
    - TP et INR > 2,3 ULN
    - TCA > 1,5 x ULN
    - Uracil blood level >16 ng/mL
    Respiratory insufficiency,
    Comorbidity precluding surgical resection, such as severe heart disease
    Other invasive malignancies in the past 3 years,
    Patient participate to an interventional study that tests another medical intervention before surgery.
    Cirrhose,
    Fonctions hématologiques, hépatiques, rénales et de coagulation inadéquates :
    - Hémoglobine ≤ 8,5 g/dl
    - Neutrophiles < 1,5 Giga/L
    - Plaquettes < 60 Giga/L
    - Bilirubine > 34µmol/L
    - ASAT/ALAT > 5 x LSN
    - Clairance de la créatinine < 30ml/min (formule MDRD)
    - TP et INR > 2,3 x LSN
    - TCA > 1,5 x LSN
    Uracilémie > 16 ng/ml,
    Insuffisance respiratoire,
    Comorbidité(s) empêchant une résection chirurgicale, telle qu’une cardiopathie sévère,
    Antécédent(s) de cancer invasif dans les 3 années précédant l'entrée dans l'essai,
    Patient déjà inclus dans un autre essai thérapeutique testant une autre intervention médicale avant la chirurgie, et tout différent type de traitement adjuvant.
    E.5 End points
    E.5.1Primary end point(s)
    Frequency of subjects with adequate surgical margins, defined as the number of resections AND margin ≥ 5mm;
    Frequency of subjects actually resected;
    Frequency of subjects with R0 and R1 resection;
    Frequency of subjects with an observed objective response;
    Mean percentage of tissue with necrosis in resected specimen;
    Disease-Free Survival (DFS);
    Overall Survival (OS).
    Fréquence des sujets présentant des marges chirurgicales adéquates, définies comme le nombre de résections ET une marge ≥ 5mm;
    Fréquence des sujets réséqués ;
    Fréquence des sujets avec une résection R0 et R1 ;
    Fréquence des sujets avec une réponse objective observée ;
    Pourcentage moyen de tissus présentant une nécrose dans les spécimens réséqués ;
    Survie sans maladie (DFS) ;
    Survie globale (OS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease-Free Survival (DFS) : will be measured from surgery to, depending on what comes first, (local or distant) recurrence or death from any cause ;
    Overall Survival (OS) : will be measured from randomization to death from any cause.
    Survie sans maladie : le délai sera mesuré à partir de la chirurgie jusqu'à, selon ce qui vient en premier, la récidive (locale ou à distance) ou le décès, quelle qu'en soit la cause ;
    Survie globale : sera mesurée à partir de la randomisation jusqu'au décès, quelle qu'en soit la cause.
    E.5.2Secondary end point(s)
    Frequency of adverse events ;
    Scores from self-questionnaires.
    Fréquence des événements indésirables ;
    Scores des auto-questionnaires.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Frequency of adverse events : from inclusion to 6 months after surgery ;
    Scores from self-questionnaires : from baseline until the end of follow-up.
    Fréquence des événements indésirables : de l'inclusion à 6 mois après la chirurgie ;
    Scores des auto-questionnaires : de l'inclusion à la fin du suivi.
    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 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
    Chirurgie seule
    Surgery 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 concerned9
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 Yes
    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 state62
    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
    Aucun
    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 Decision2021-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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