[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Azienda Sanitaria Ospedaliera\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100525748","liver-transplantation-for-non-resectable-peri-hilar-cholangiocarcinoma-litalhica-100525748",false,"NCT06125769","LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)","LITALHICA","Inclusion Criteria:\n\n* Diagnosis of pCCA (transcatheter biopsy or brush cytology, CA 19-9 \\> 100 mg\u002FmL and\u002For a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography, or biliary ploidy with a malignant appearing stricture on cholangiography)\n* Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC\n* Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes\n* No extrahepatic metastatic disease\n* Radial tumor diameter ≤3 cm\n* At least six months between first diagnosis of pCCA and date of inclusion\n* At least six months of SOC chemotherapy, achieving disease stability or partial response\n\nExclusion Criteria:\n\n* Uncontrollable infection\n* Prior radiotherapy or chemotherapy\n* Prior biliary surgical resection or attempted surgical resection\n* Diameter of tumor \\>3cm\n* Presence of intra-hepatic metastases or iCCA\n* Present or past evidence of extrahepatic metastatic disease\n* Transperitoneal biopsy (including percutaneous ecography-guided FNA)\n* Prior neoplasms, except those treated curatively for more than 5 years without recurrence\n* Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study\n* Pregnant or breastfeeding women\n* Medical-surgical contraindications for liver transplantation","ALL","18 Years","70 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment with standard of care chemotherapy, in terms of overall survival and quality of life. Additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. Finally, the study aims to investigate the role of preoperative PET-MRI, especially in relation to lymph node locations, by correlating the results with histological examination after hilar lymphadenectomy.",[27],"Perihilar Cholangiocarcinoma",[29],"Liver transplantation","RECRUITING","2026-03-30",{"date":33,"type":34},"2026-04-03","ACTUAL",{"date":36,"type":34},"2024-01-15",{"date":38,"type":21},"2033-11-01",{"name":40,"class":41},"Azienda Sanitaria Ospedaliera","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":61,"leadSponsor":62,"locationsCount":42},"100523657","liver-transplantation-for-non-resectable-intrahepatic-cholangiocarcinoma-lirica-100523657","NCT06098547","LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)","LIRICA","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of iCCA\n* First diagnosis of iCCA\n* Recurrence after R0 hepatic resection, N0, M0 without macrovascular invasion\n* Disease considered unsuitable for hepatic resection based on tumor location and extent or underlying liver dysfunction\n* Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes detected on radiological study\n* No evidence of extrahepatic metastatic disease after chest-abdomen-pelvis CT and PET-MR (or PET-CT)\n* At least six months have passed since the first diagnosis of iCCA (or recurrence) to the date of inclusion on the liver transplant waiting list\n* The patient has received at least six months of SOC chemotherapy, achieving disease stability or partial response (according to RECIST version 1.1) at the time of listing for transplantation\n* Hematochemical evaluation: Hb ≥ 9 g\u002FdL, Leukocytes ≥ 3.0 X 109\u002FL, Neutrophils ≥ 1.5 X 109\u002FL, Platelets ≥ 100,000\u002Fmm3 (≥ 10 X 109\u002FL), Total Bilirubin ≤ 3 mg\u002FdL (≤ 51 umol\u002FL), AST or ALT ≤ 5 times the upper limit of normal, Serum Creatinine and Urea \\\u003C 1.5 times the upper limit of normal\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1\n* Patient's BMI ≥ 18 and ≤ 30 kg\u002Fm2\n* Signed informed consent, and expected patient cooperation for treatment and follow-up, must be obtained and documented according to good clinical practice and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* Tumor involving nearby extrahepatic structures (including involvement of major hepatic vessels) by direct invasion (T4 per AJCC 8th edition)\n* Tumor penetrating the visceral peritoneum (T3 per AJCC 8th edition)\n* Previous extrahepatic metastatic disease\n* Prior neoplasms, except those treated curatively for more than 5 years without recurrence\n* Known history of human immunodeficiency virus (HIV) infection\n* Known history of solid organ or bone marrow transplantation\n* Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study or with the evaluation of study outcomes\n* Pregnant or breastfeeding women\n* Medical-surgical contraindications for liver transplantation\n* Any reason for which, in the investigator's judgment, the patient should not participate in the study",{"count":51,"type":21},10,[24],"LIRICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable iCCA after a downstaging\u002Fdisease control protocol with standard of care chemotherapy, in terms of overall survival and quality of life. Additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. Finally, the study aims to investigate the role of preoperative PET-MR, especially in relation to lymph node locations, by correlating the results with histological examination after iliac lymphadenectomy.",[55],"Intrahepatic Cholangiocarcinoma",[29],"2024-01-23",{"date":59,"type":34},"2024-01-24",{"date":36,"type":34},{"date":38,"type":21},{"name":40,"class":41},""]