[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582409":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":25,"responsibleParty":52,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Transplant",null,"Patients enrolled within the study who undergo downstaging and liver transplantation after with various combinations of chemotherapy +\u002F- immunotherapy and TARE",{"label":13,"type":10,"description":14,"interventionNames":10},"Controls 1 (unresectable)","Historical controls with the same inclusion criteria as the iCOLA protocol, treated with systemic and locoregional therapies and prospectively recruited patients with tumor response who refused transplantation or were not found eligible to LT for medical\u002Fnon-oncological conditions",{"label":16,"type":10,"description":17,"interventionNames":10},"Controls 2 (resectable)","Patients with resectable iCC who underwent curative-intent liver resection, matched to the transplanted patients using demographic characteristics, tumor burden and pre-surgical therapies",[19],{"name":20,"role":21,"phone":22,"phoneExt":23,"email":24},"Vincenzo Mazzaferro, MD, PhD","CONTACT","0223902760","+39","vincenzo.mazzaferro@istitutotumori.mi.it",[26],{"facility":27,"status":28,"city":29,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Fondazione IRCCS Istituto Nazionale Tumori di Milano","RECRUITING","Milan","20133","Italy","IT",{"type":34,"coordinates":35},"Point",[36,37],9.18951,45.46427,{"lat":37,"lon":36},[40,44,46,49,50],{"name":41,"role":21,"phone":42,"phoneExt":23,"email":43},"Marianna Maspero, MD","0223904066","marianna.maspero@istitutotumori.mi.it",{"name":20,"role":45,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":47,"role":48,"phone":10,"phoneExt":10,"email":10},"Carlo Sposito, MD","SUB_INVESTIGATOR",{"name":41,"role":48,"phone":10,"phoneExt":10,"email":10},{"name":51,"role":48,"phone":10,"phoneExt":10,"email":10},"Marco Bongini, MD, Ms",{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100582409","liver-transplantation-for-unresectable-intrahepatic-colangiocarcinoma-after-sustained-response-to-neoadjuvant-treatments-100582409",false,"NCT06862934","Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments","Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments (iCOLA)","iCOLA","Inclusion Criteria:\n\n* Histological diagnosis of iCCA (biopsy-proven tumor)\n* Either first diagnosis or post-resection recurrence (occurring ≥ 6 months after resection)\n* Unresectability assessment due to tumor location (leading to insufficient live remnant with\u002Fout implementation of hypertrophic parenchymal techniques) or underlying liver disease. Non-resectability assessed by an expert surgical team with experience on both resection and transplantation (centralized at INT Milan).\n* Age between 18 and 70 years\n* No macrovascular tumor invasion (NB: portal vein and\u002For hepatic vein occlusion from the external tumor compression and classified as \"encasement\" could be considered after expert radiology review)\n* No extrahepatic spread\n* Disease stability for at least 6 months\n* CA 19-9 \\\u003C 200 u\u002Fml at transplant listing in absence of jaundice\n* No medical and surgical contraindications to liver transplantation\n* Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1\n* No concomitant malignancies or history of other malignancies in the previous 5 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Hilar and distal cholangiocarcinoma\n* Progression of disease under chemotherapy +\u002F- radiation therapy, assessed with either RECIST, mRECIST or Choi criteria\n* Evidence of lymph-nodal metastases\n* Evidence of extrahepatic disease\n* Prior extrahepatic metastatic disease\n* Concomitant malignancies or history of other malignancies in the previous 5 years\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n* Any reason why, in the opinion of the investigator, the patient should not participate to the study","ALL","18 Years","70 Years",{"count":66,"type":67},14,"ESTIMATED","OBSERVATIONAL","This is single-arm, observational, academic, investigator-driven study investigating the efficacy of liver transplantation after successful and sustained downstaging\u002Ftumor control of liver-limited unresectable intrahepatic cholangiocarcinoma. The downstaging protocol includes chemotherapy +\u002F- immunotherapy and transarterial radioembolization (TARE) with Yttrium-90 in various combinations.",[71],"Intrahepatic Cholangiocarcinoma (Icc)",[73,74,75],"liver transplantation","transarterial radioembolization","downstaging","2025-03-03",{"date":78,"type":79},"2025-03-06","ACTUAL",{"date":81,"type":67},"2025-03-20",{"date":83,"type":67},"2027-12-31",{"name":5,"class":6},1]