protocolSection identificationModule nctId: NCT06341764, orgStudyIdInfo id: CITATION, secondaryIdInfos id: 7/23, type: OTHER, domain: IRCCS I.N.T. "G. Pascale", briefTitle: Neo-adjuvant Chemo and Immunotherapy in The Pre-operAtive Treatment of Locally Advanced cholangIOcarciNoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute, Naples, class: OTHER, descriptionModule briefSummary: Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery., conditionsModule conditions: Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Durvalumab 1120 mg, interventions name: Durvalumab 1500 mg, interventions name: Tremelimumab i.v. at 300 mg, interventions name: Cisplatin (CDDP) 25 mg/mq i.v, interventions name: Gemcitabine (GEM) 1000 mg/mq i.v., outcomesModule primaryOutcomes measure: Recurrence rate of CCA, secondaryOutcomes measure: Rate of R0 resections, secondaryOutcomes measure: Radiologic responses, secondaryOutcomes measure: Pathologic responses, secondaryOutcomes measure: Toxicity assessed, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, otherOutcomes measure: Exploratory objectives, otherOutcomes measure: Exploratory objectives, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale, status: RECRUITING, city: Napoli, state: Italia, zip: 80131, country: Italy, contacts name: Alessandro Ottaiano, role: CONTACT, phone: 08117770344, email: a.ottaiano@istitutotumori.na.it, contacts name: Alessandro Ottaiano, role: PRINCIPAL_INVESTIGATOR, contacts name: Guglielmo Nasti, role: SUB_INVESTIGATOR, contacts name: Francesco Izzo, role: SUB_INVESTIGATOR, contacts name: Andrea Belli, role: SUB_INVESTIGATOR, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale Cardarelli, Napoli, status: NOT_YET_RECRUITING, city: Napoli, state: Italia, zip: 80131, country: Italy, contacts name: Giovanni Vennarecci, role: CONTACT, phone: 0817472372, email: giovanni.vennarecci@aocardarelli.it, contacts name: Giovanni Vennarecci, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Università di Napoli "Federico II", Napoli, status: NOT_YET_RECRUITING, city: Napoli, state: Italia, zip: 80131, country: Italy, contacts name: Roberto Bianco, role: CONTACT, phone: 0817462061, email: robianco@unina.it, contacts name: Roberto Bianco, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale san Camillo Forlanini/Spallanzani, Roma, status: NOT_YET_RECRUITING, city: Roma, state: Italia, zip: 00152, country: Italy, contacts name: Viola Barucca, role: CONTACT, phone: 3391333211, email: viola.barucca.scf@gmail.com, contacts name: Viola Barucca, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Mauriziano, Umberto I°, status: NOT_YET_RECRUITING, city: Torino, state: Italia, zip: 10128, country: Italy, contacts name: Massimo Di Maio, role: CONTACT, phone: 0115082032, email: massimo.dimaio@unito.it, contacts name: Massimo Di Maio, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Università di Verona, Ospedale Borgoroma, Verona, status: NOT_YET_RECRUITING, city: Verona, state: Italia, zip: 37134, country: Italy, contacts name: Alessandra Auriemma, role: CONTACT, phone: 3483148292, email: alessandra.auriemma@aovr.veneto.it, contacts name: Alessandra Auriemma, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False