[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perihilar-cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perihilar-cholangiocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,44,68,95,130,154,178,208],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100481236","endobiliary-radiofrequency-ablation-for-malignant-biliary-obstruction-due-to-perihilar-cholangiocarcinoma-100481236",false,"NCT05546372","Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma","Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial","RACCOON","Inclusion Criteria:\n\n* 18 years or older.\n* Capable of providing written and oral informed consent.\n* Histological or cytological proof of perihilar CCA (adenocarcinoma).\n* Perihilar biliary obstruction with an indication for drainage with uSEMS.\\*\n* Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2) involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT).\n\n  * Only patients with pCCA are eligible however in case of reasonable doubt between intrahepatic CCA with a perihilar biliary obstruction or massforming pCCA, patients can be included.\n\nExclusion Criteria:\n\n* Patients who potentially qualify for curative resection of pCCA.\n* pCCA eligible for liver transplantation.\n* Life-expectancy less than 3 months.\n* ERCP and PTC technically not feasible.\n* Uncontrolled coagulopathy (PTT \\>1,5x prolonged or thrombocytes below 40\\*10E9\u002FL).\n* Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and\u002For liver abscess at least 7 days.\n* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.\n* Patients who are pregnant or breastfeeding.","ALL","18 Years",{"count":20,"type":21},122,"ESTIMATED","INTERVENTIONAL",[24],"NA","A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.",[27],"Perihilar Cholangiocarcinoma",[29,30],"Endobiliary radiofrequency ablation","Stent patency","RECRUITING","2026-05-21",{"date":34,"type":35},"2026-05-26","ACTUAL",{"date":37,"type":35},"2022-10-22",{"date":39,"type":21},"2027-06-30",{"name":41,"class":42},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100525748","liver-transplantation-for-non-resectable-peri-hilar-cholangiocarcinoma-litalhica-100525748","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","70 Years",{"count":53,"type":21},50,[24],"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],[58],"Liver transplantation","2026-03-30",{"date":61,"type":35},"2026-04-03",{"date":63,"type":35},"2024-01-15",{"date":65,"type":21},"2033-11-01",{"name":67,"class":42},"Azienda Sanitaria Ospedaliera",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":43},"100472347","phase-2-pd-1-antibody-plus-gemox-as-postoperative-adjuvant-therapy-in-perihilar-cholangiocarcinoma-100472347","NCT05430698","PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma","PD-1 Antibody Plus Gemcitabine and Oxaliplatin (GEMOX) as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma Patients With Positively Metastatic Lymph Nodes : a Single Arm, Phase II Trial","Inclusion Criteria:\n\n1. The patient must sign an informed consent form;\n2. Age 18-75 years old, both male and female;\n3. ECOG performance status score (PS score) 0 or 1 point;\n4. Child-Pugh score A period;\n5. Perihepatic cholangiocarcinoma with negative margins and positively metastatic lymph nodes confirmed by histopathology. Abdominal positively metastatic lymph nodes region is not limited. The 16 groups of microscopically positively metastatic lymph nodes can be included.\n6. Have not received any systemic treatment within 6 months;\n7. The functional indicators of important organs meet the following requirements (1)Neutrophils≥1.5\\*109\u002FL; platelets≥100\\*109\u002FL; hemoglobin≥9g\u002Fdl; serum albumin≥3g\u002Fdl; (2)Thyroid-stimulating hormone (TSH) ≤ 2 times the upper limit of normal, and T3 and T4 are in the normal range; (3)Bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 3 times the upper limit of normal; (4)Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 60ml\u002Fmin (calculated by Cockcroft-Gault formula); 8. The subject has at least 1 measurable lesion (according to RECIST1.1);\n8. For women who are not breastfeeding or pregnant, use contraception during treatment or 12 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Unresectable PHC patients or postoperative diagnosis of PHC recurrence and metastasis ;\n2. Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma;\n3. Have used gemcitabine-based chemotherapy or have used PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment within 6 months;\n4. Severe cardiopulmonary and renal dysfunction;\n5. Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and\u002For diastolic blood pressure ≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2 measurements);\n6. Abnormal coagulation function (PT\\>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy;\n7. After antiviral treatment, HBV DNA\\>2000 copies\u002Fml, HCV RNA\\>1000;\n8. A history of esophageal and gastric varices, significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;\n9. Active infections requiring systemic treatment; patients with active tuberculosis infection within 1 year before enrollment; a history of active tuberculosis infection more than 1 year before enrollment, and no formal anti-tuberculosis treatment or tuberculosis Still in the active period;\n10. Human immunodeficiency virus (HIV, HIV1\u002F2 antibody) positive;\n11. A history of psychotropic drug abuse, alcohol or drug abuse;\n12. Known to have a history of severe allergies to any monoclonal antibodies, platinum drugs, or gemcitabine;\n13. Other factors judged by the investigator may affect the safety of the subjects or the compliance of the trial. Such as serious diseases (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.","75 Years",{"count":77,"type":21},62,[79],"PHASE2","This is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.",[27],[83,84,27,85],"PD-1","GEMOX","Positively Metastatic Lymph Nodes","2026-02-05",{"date":88,"type":35},"2026-02-09",{"date":90,"type":35},"2023-01-31",{"date":92,"type":21},"2027-12-31",{"name":94,"class":42},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":105,"studyType":106,"phases":4,"briefSummary":107,"conditions":108,"keywords":114,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":43},"100605388","preoperative-evaluation-of-lymph-nodes-of-cholangiocarcinoma-poelh-iii-100605388","NCT07161869","Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma (POELH-III)","Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma by Endoscopic Ultrasound (POELH-III)","POELH-III","Inclusion Criteria:\n\n* Presumed resectable pCCA OR\n* Presumed resectable iCCA OR\n* Presumed resectable mid-common bile duct CCA OR\n* Presumed unresectable pCCA worked-up for Liver Transplantation AND\n* Written informed consent must be given according to International Council on Harmonisation\u002FGood Clinical Practice guidelines, and national\u002Flocal regulations AND\n* Age \\> 18 years.\n\nExclusion Criteria:\n\n* Patients with a history of treated CCA\n* Patients with CCA for which a pancreatoduodenectomy is indicated, based on cross-sectional imaging\n* Patients with a history of treated liver malignancy\n* Patients with a contra-indication for EUS-tissue acquisition (f.e. uncorrectable coagulopathy or platelet disorder), in line with current clinical practice",{"count":104,"type":21},250,"12 Months","OBSERVATIONAL","In the POELH-II trial (Clinicaltrials.gov ID NCT05678218) patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma had the outcomes of their preoperative endoscopic ultrasound (EUS) registered. This EUS procedure was done systematically, targeting lymph nodes (LNs) with the aim to identify LN metastases preoperatively.\n\nThe goal of this follow-up observational cohort study (POELH-III) is to assess the yield of preoperative EUS, with an improved EUS approach. The EUS protocol as used in the POELH-II trial was improved based on preliminary results of the POELH-II trial. The main questions it aims to answer is:\n\n\\- The number of patients precluded from surgical work-up due to positive regional or extraregional LNs identified by EUS guided tissue acquisition",[109,110,111,27,112,113],"Hilar Cholangiocarcinoma","Intrahepatic Cholangiocarcinoma (Icc)","Cholangiocarcinoma","Common Bile Duct Neoplasms","Adenocarcinoma of Biliary Tract",[115,116,117,118,119],"poelh","EUS","Lymph node","cholangiocarcinoma","biliary tract cancer","NOT_YET_RECRUITING","2025-09-08",{"date":123,"type":35},"2025-09-09",{"date":125,"type":21},"2025-10-01",{"date":127,"type":21},"2028-11-01",{"name":129,"class":42},"Erasmus Medical Center",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":43},"100438734","liver-transplantation-for-non-resectable-perihilar-cholangiocarcinoma-100438734","NCT04993131","Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma","Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma: a Prospective Exploratory Trial","TESLA II","Inclusion criteria\n\n* Radiologically strong suspicion of pCCA\n* Tumor can involve intrahepatic portal vein without thrombosis of extrahepatic portal vein\n* Tumor can involve hepatic artery distal to gastroduodenal artery or involve replaced hepatic artery\n* First time pCCA\n* Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction\n* No extrahepatic disease, or lymph node involvement detected on imaging\n* No signs of extrahepatic metastatic disease according to PET-CT scan\n* No signs of extrahepatic metastatic disease according to CT or MR (chest\u002Fabdomen\u002Fpelvis) scan within 4 weeks prior to the faculty meeting at the transplant unit\n* At least 18 years of age\n* Good performance status, Eastern Cooperative Oncology Group (ECOG) score: 0 or 1\n* Satisfactory blood tests Hb \\>10g\u002Fdl, neutrophiles \\>1.0 (after any G-CSF), TRC \\>50, Bilirubin\\\u003C3 x upper normal level, ASAT, ALAT\\\u003C5 x upper normal level, Creatinine \\\u003C1.5 x upper normal level. Albumin above lower normal level, Normal IgG4 levels\n* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national\u002Flocal regulations\n* Received chemotherapy for at least 6 months with at least 10% response according ti RECIST criteria and with no progression of disease at time of Lt\n* At least 10 months from diagnosis\n* Patient must be accepted for transplantation before progressive disease\n* Twelve months or more time span from the diagnosis of pCCA and date of being listed for liver transplantation\n\nExclusion criteria\n\n* Tumor involving common hepatic artery, celiac trunck or superior mesenteric artery the tumor\n* Tumor involving main portal vein\n* Tumor involving inferior vena cava\n* Perforation of the visceral peritoneum\n* Weight loss \\>15% the last 6 months\n* Patient BMI \\> 30\n* Other malignancies, except curatively treated more than 5 years ago without relapse\n* Known history of human immunodeficiency virus (HIV) infection\n* Prior history of solid organ or bone marrow transplantation\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* Known hypersensitivity to rapamycin\n* Prior extrahepatic metastatic disease\n* Women who are pregnant or breast feeding\n* Any reason why, in the opinion of the investigator, the patient should not participate",{"count":139,"type":21},15,[24],"The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated.",[27,143,144],"Klatskin Tumor","Bile Duct Cancer","2025-07-28",{"date":147,"type":35},"2025-07-31",{"date":149,"type":35},"2021-09-01",{"date":151,"type":21},"2045-05-31",{"name":153,"class":42},"Oslo University Hospital",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":162,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":43},"100591904","liver-transplantation-for-unresectable-perihilar-cholangiocarcinoma-100591904","NCT06986486","Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma","Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA","pCOLA","Inclusion Criteria:\n\n* Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by:\n* Transcatheter biopsy or brush cytology\n* CA-19.9 \\> 100 mg\u002Fml and\u002For a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography\n* Biliary ploidy by FISH with a malignant appearing stricture on cholangiography\n* Age between 18 years and 70 years\n* Absence of intra- and extrahepatic metastases\n* Absence of lymph-nodal metastases at any site\n* Biliary stenting of all liver districts\n* No contraindications to liver transplantation\n* No concomitant malignancies or history of other malignancies in the previous 5 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Intrahepatic cholangiocarcinoma\n* Uncontrolled infection\n* Concomitant malignancies or history of other malignancies in the previous 5 years",{"count":5,"type":21},"This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging\u002Fdisease control of unresectable perihilar cholangiocarcinoma using chemotherapy +\u002F- immunotherapy and stereotactic body radiation therapy (SBRT).",[27,143],[166,167,168],"liver transplantation","stereotactic body radiation therapy","downstaging","2025-05-15",{"date":171,"type":35},"2025-05-23",{"date":173,"type":21},"2025-06-01",{"date":175,"type":21},"2030-01-01",{"name":177,"class":42},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":190,"conditions":191,"keywords":196,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":43},"100587060","phase-2-neoadjuvant-gemcitabine-and-cisplatin-in-combination-with-perioperative-pembrolizumab-versus-upfront-surgery-for-patients-with-primary-resectable-and-borderline-resectable-perihilar-and-distal-cholangiocarcinoma-100587060","NCT06923475","Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma","Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma (NEODISCO): A Multicentre Phase 2B\u002F3 Randomized Controlled Trial","NEODISCO","Inclusion Criteria:\n\n* Histologically or cytologically confirmed resectable or borderline resectable pCCA and dCCA. These are all the patients considered candidates for upfront surgical exploration, with intent to resect, as confirmed by local MDT and the study expert panel also taking into consideration endoscopic and radiological findings. In cases where drainage is not required, patients with a disease highly suspicious for extrahepatic cholangiocarcinoma, as determined by the expert MDT, may be included without histological proof to prevent unnecessary post-ERCP complications.\n* Successful drainage, in case of clinical significant bile duct obstruction.\n* MidCCA inclusion in the NEODISCO-trial will be permitted and will be included according to the proposed type of resection.\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n\nExclusion Criteria:\n\n* Upfront \"clearly\" unresectable pCCA: circumferential unreconstructable vascular involvement of the FLR and\u002For insufficient FLR for potential radical resection. Insufficient FLR is defined as \\\u003C30% residual volume or a function \\\u003C2.7 min\u002Fm2. Patients considered borderline resectable but, by the discretion of the MDT, not a candidate for upfront exploration\u002Fresection, are considered ineligible for NEODISCO.\n* Upfront clearly unresectable dCCA (following DPCG criteria).\n* Patients with proven N2 lymph nodes (according to the AJCC 8th edition).\n* PCCA eligible for liver transplantation.\n* Intrahepatic cholangiocarcinoma with hilar involvement.\n* Cancer suspicious for ampullary carcinoma (for instance involvement of papilla during endoscopy).\n* Local recurrence following prior resection of eCCA (patients who develop local recurrence during the study are however not excluded).\n* Patients with underlying liver diseases: PSC, untreated hepatitis, cirrhosis child-Pugh B, C.\n* Previous malignancy unless no evidence of disease, or diagnosed more than 3 years before diagnosis of eCCA, or with a life expectancy of more than 5 years from date of inclusion.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).",{"count":187,"type":21},150,[79,189],"PHASE3","Extrahepatic cholangiocarcinoma (eCCA) is a rare and aggressive cancer with poor prognosis. ECCA can be further subcategorised in perihilar and distal cholangiocarcinoma (pCCA and dCCA). Surgical resection is the only potential cure, but only one-third of patients are eligible. Even among those deemed resectable, a significant portion (≈30%) experience disease progression before surgery, while another 30% are found unresectable during exploration. High recurrence rates and postoperative complications further limit survival, with 5-year overall survival ranging from 13% (R1 resection) to 40% (R0 resection). Given the long preoperative work-up period and lack of treatment during this phase, a neoadjuvant approach may improve outcomes by increasing R0 resections, reducing recurrence, and optimizing patient selection.\n\nThis multicenter, randomized phase 2B\u002F3 trial aims to assess whether neoadjuvant gemcitabine and cisplatin plus perioperative pembrolizumab improves event-free survival in patients with resectable and borderline resectable pCCA and dCCA.",[192,27,193,194,195],"Extrahepatic Cholangiocarcinoma","Distal Cholangiocarcinoma","Resectable","Borderline Resectable",[197,27,193,194,198],"Extrahepatic cholangiocarcinoma","Borderline resectable","2025-04-03",{"date":201,"type":35},"2025-04-11",{"date":203,"type":21},"2025-05-05",{"date":205,"type":21},"2028-11-06",{"name":207,"class":42},"Amsterdam UMC, location VUmc",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":217,"studyType":106,"phases":4,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":43},"100571486","robotically-assisted-surgery-for-perihilar-cholangiocarcinoma-a-prospective-study-100571486","NCT06720883","Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study","ROBOCHOL","Inclusion Criteria:\n\n* Age≥18 years\n* Histologically proven pCCA or highly presumed bile duct malignancy with difficulties to obtain histological evidence with negative Immunoglobulin G4 (IgG4 sample)\n* Preoperative staging work up performed by abdomen enhanced CT scan.\n* The subject understands the nature of this trial and is willing to comply.\n* Ability to provide written informed consent.\n* Patients treated with curative intent in accordance to international guidelines\n\nExclusion Criteria:\n\n* Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.\n* Previous radiotherapy\n* Vascular encasement\n* Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score\\>4.\n* Synchronous malignancy in other organs.\n* Palliative surgery",{"count":216,"type":21},32,"5 Years","Cholangiocarcinoma (CCA) represents the most common biliary tract malignancy, and the second most common primary hepatic malignancy, accounting for 15% to 20% of primary liver tumours.\n\nPerihilar cholangiocarcinoma (pCCA) involves the biliary confluence with or without involvement of the right and left hepatic ducts. Complete resection with negative histologic margins is the only chance of cure and the most robust predictor of long-term survival for patients affected by any type of locally advanced CCA. However, the proximity of perihilar tumors to vital structures makes curative excision technically difficult.\n\nMinimally invasive approaches are progressively spreading in liver surgery units worldwide. Significant advantages of minimally invasive liver resections, if compared to open one, have been diffusely shown, such as shorter hospital stay and possibility of complex reconstructive procedures similar to those performed in open surgery. Robot-assisted liver surgery represents a natural consequence of such a minimally invasive evolution.\n\nThis is a monocentric, single arm, observational, prospective study that aims at analyzing the outcomes of robotic major liver resection and biliary recontruction for perihilar cholangiocarcinoma.\n\nAmong study outcomes, the primary outcome is evaluation of morbidity; secondary outcomes includes conversion rate, margin status, biliary fistula, liver failure, disease specific survival, overall Survival\n\nData related to patient condition (laboratory tests, etc.), surgery performed, and post-surgical course will be collected.\n\nThe protocol for this study has been developed in accordance with the European Union Good Clinical Practice guidelines and the Declaration of Helsinki, and it has been approved by the Territorial Ethics Committee of the East-Central Veneto Area (CETAEV).",[220,27],"Cholangiocarcinoma Cancer",[118,222,223,224,225,226],"robot","robotic","perihilar","cca","phc","2024-12-05",{"date":229,"type":35},"2024-12-06",{"date":231,"type":35},"2024-06-07",{"date":233,"type":21},"2031-07-07",{"name":235,"class":42},"Azienda Ospedaliera di Padova"]