[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hilar-cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hilar-cholangiocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,56,87,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100595260","phase-2-phase-ii-study-of-neoadjuvant-tislelizumab-plus-radiotherapy-and-gp-chemotherapy-for-borderlineunresectable-hilar-cholangiocarcinoma-100595260",false,"NCT07030140","Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline\u002FUnresectable Hilar Cholangiocarcinoma","A Phase II, Single-arm, Prospective Clinical Study of Neoadjuvant Therapy With Tislelizumab Combined With Radiotherapy and Gemcitabine-Platinum Chemotherapy for Borderline Resectable or Unresectable Hilar Cholangiocarcinoma","Inclusion Criteria:\n\n* Age 18-75 years, histologically or cytologically confirmed hilar cholangiocarcinoma\n* Borderline resectable or unresectable disease based on imaging and MDT evaluation\n* ECOG performance status 0-1\n* Adequate hematologic, hepatic, and renal function\n* No prior anti-tumor therapy for current diagnosis\n* Expected survival ≥ 3 months\n* Signed informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastasis\n* Prior treatment with immune checkpoint inhibitors\n* Uncontrolled infection or serious medical comorbidities\n* Active autoimmune disease requiring systemic therapy\n* History of organ transplantation or immunodeficiency\n* Pregnancy or lactation","ALL","18 Years","75 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase II, single-arm, prospective clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy combining stereotactic body radiotherapy (SBRT), GP chemotherapy (gemcitabine and cisplatin\u002Foxaliplatin), and tislelizumab in patients with borderline resectable or unresectable hilar cholangiocarcinoma. Eligible patients will receive SBRT followed by three cycles of tislelizumab plus GP chemotherapy. Patients with resectable disease after evaluation may undergo surgery and receive postoperative treatment as recommended by the multidisciplinary team. Those who remain unresectable will receive three additional cycles of systemic therapy. The primary endpoint is overall survival (OS); secondary endpoints include R0 resection rate, pathological complete response (pCR), surgical difficulty, progression-free survival (PFS), local control rate, and treatment-related safety.",[27,28,29],"Cholangiocarcinoma","Hilar Cholangiocarcinoma","Bile Duct Cancer",[31,32,33,34,35,36,37,38,39,40,41,42],"Borderline Resectable","Unresectable","SBRT","Tislelizumab","Gemcitabine","Cisplatin","Oxaliplatin","Neoadjuvant Therapy","Immunotherapy","Radiation Therapy","PD-1 Inhibitor","Biliary Tract Cancer","RECRUITING","2026-04-27",{"date":46,"type":47},"2026-05-01","ACTUAL",{"date":49,"type":47},"2025-07-01",{"date":51,"type":21},"2028-01-01",{"name":53,"class":54},"Jinbo Yue","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":16,"minAge":17,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":85,"locationsCount":55},"100606546","a-cell-free-dna-methylation-blood-based-test-for-biliary-tract-cancers-screening-100606546","NCT07176962","A Cell-free DNA Methylation Blood-Based Test for Biliary Tract Cancers Screening","A Cell-free DNA Methylation Liquid Biopsy for Diagnosis and Management of Biliary Tract Cancers","Inclusion Criteria Internal Training and Validation Cohorts\n\n* BTC patients\n\n  1. Willing to voluntarily participate and able to comply with study procedures; if unable to read or sign, informed consent must be signed by a legally authorized representative (LAR).\n  2. Age 18-80 years (inclusive).\n  3. Able to provide required blood samples.\n  4. Pathologically confirmed biliary tract carcinoma (TNM stage I-IV).\n  5. Stable vital signs; ECOG performance status 0-1.\n  6. Adequate organ function: AST\u002FALT ≤ 5 × ULN; Child-Pugh class A or B; WBC \\> 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; Total bilirubin ≤ 3 × ULN.\n* Other gastrointestinal malignancies (to exclude BTC non-specific signals)\n\n  1. Voluntary participation with signed informed consent (or by LAR).\n  2. Age 18-80 years (inclusive).\n  3. Able to provide required blood samples.\n  4. Pathologically confirmed gastrointestinal malignancies other than BTC, including hepatocellular carcinoma, gastric cancer, colorectal cancer, and pancreatic cancer (TNM stage I-IV).\n  5. Stable vital signs; ECOG performance status 0-1.\n* Non-cancer participants (benign biliary disease)\n\n  1. Able to provide written informed consent.\n  2. Able to provide required blood samples.\n  3. Age 18-80 years (inclusive).\n  4. Pathologically or clinically diagnosed benign biliary diseases, including cholecystitis, cholelithiasis, choledocholithiasis, adenomyomatosis, gallbladder polyps, xanthogranulomatous cholecystitis, or primary sclerosing cholangitis.\n\nExternal Validation Cohorts\n\n* BTC patients\n\n  1. Voluntary participation with signed informed consent (or by LAR).\n  2. Imaging findings of malignant biliary stricture or mass, or serum CA19-9 \\> 100 U\u002FmL, highly suspicious for BTC, with planned surgery or biopsy for pathological confirmation.\n  3. Age 18-80 years (inclusive).\n  4. Able to provide required blood samples.\n  5. Stable vital signs; ECOG performance status 0-1.\n  6. Adequate organ function: AST\u002FALT ≤ 5 × ULN; Child-Pugh class A or B; WBC \\> 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; Total bilirubin ≤ 3 × ULN.\n* Healthy volunteers\n\n  1. Able to provide written informed consent.\n  2. Able to provide required blood samples.\n  3. Age 18-80 years (inclusive).\n\nExclusion Criteria Training and Validation Cohorts\n\n* Cancer patients\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of curative cancer treatment within 3 years prior to blood collection.\n  5. Use of anti-tumor drugs within 30 days prior to blood collection.\n  6. Known bleeding disorders.\n  7. Known autoimmune diseases.\n  8. Concurrent other malignancies or multiple primary tumors.\n* Non-cancer participants\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of any malignant tumor.\n  5. Known bleeding disorders.\n  6. Known autoimmune diseases.\n  7. Clinically significant abnormalities on routine examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).\n\nExternal Validation Cohorts\n\n* Cancer patients\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of or ongoing curative cancer treatment within 3 years prior to blood collection.\n  5. Use of anti-tumor drugs within 30 days prior to blood collection.\n  6. Known bleeding disorders or autoimmune diseases.\n  7. Concurrent other malignancies (including multiple primaries) or known cancer susceptibility gene carriers.\n  8. Pathology confirmed benign disease after biopsy\u002Fsurgery.\n  9. Failure to confirm malignancy by pathology or imaging within 42 days after blood collection, or unclear lesion site\u002Fevidence.\n  10. Special exclusion criteria:\n* Pathology confirmed precancerous lesions.\n* Any local\u002Fregional or systemic anti-tumor therapy (including surgery, radiotherapy, targeted therapy, or immunotherapy) prior to blood collection.\n* Healthy volunteers\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of any malignant tumor.\n  5. Known bleeding disorders or autoimmune diseases.\n  6. Clinically significant abnormalities on health examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).",true,"80 Years",{"count":66,"type":21},1800,"OBSERVATIONAL","Biliary tract carcinoma (BTC), including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, ranks sixth in incidence among gastrointestinal malignancies and tenth in cancer-related mortality worldwide. Due to the lack of specific early symptoms, high malignancy, and frequent recurrence and metastasis, the rate of curative resection is only about 16.5%, and the overall 5-year survival rate is less than 5%. Early and accurate detection is therefore critical for improving patient outcomes. Circulating tumor DNA (ctDNA), a fraction of circulating free DNA (cfDNA), carries genetic and epigenetic information from tumor cells and can be detected even at the early stages of cancer development. Among various liquid biopsy biomarkers, ctDNA methylation shows particular advantages in sensitivity and specificity for early cancer detection and monitoring. This study aims to evaluate the application of cfDNA methylation liquid biopsy in the diagnosis and management of BTC.",[70,71,72,28,73,74],"Gall Bladder Cancer","Intrahepatic Cholangiocarcinoma (Icc)","Extrahepatic Cholangiocarcinoma","Billiary Track Cancer","ctDNA",[76,77,78,73],"ctDNA methylation","Early diagnosis","Liquid biopsy","2025-09-10",{"date":81,"type":47},"2025-09-16",{"date":83,"type":47},"2020-01-01",{"date":46,"type":21},{"name":86,"class":54},"Yingbin Liu, MD, PhD, FACS",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":97,"studyType":67,"phases":4,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":55},"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":96,"type":21},250,"12 Months","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",[28,71,27,100,101,102],"Perihilar Cholangiocarcinoma","Common Bile Duct Neoplasms","Adenocarcinoma of Biliary Tract",[104,105,106,107,108],"poelh","EUS","Lymph node","cholangiocarcinoma","biliary tract cancer","NOT_YET_RECRUITING","2025-09-08",{"date":112,"type":47},"2025-09-09",{"date":114,"type":21},"2025-10-01",{"date":116,"type":21},"2028-11-01",{"name":118,"class":54},"Erasmus Medical Center",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100481614","phase-4-treatment-of-non-resectable-bile-duct-cancer-with-radiofrequency-ablation-or-photodynamic-therapy-100481614","NCT05551299","Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy","Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial","CARP","Inclusion Criteria:\n\n1. Hilar cholangiocarcinoma (cytological or histological confirmation)\n2. Surgery is not planned\n3. Age ≥ 18 years\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Tumour not accessible endoscopically\n2. Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen\n3. Leukopenia (\\\u003C 2000\u002Fmm3)\n4. Thrombocytopenia (\\\u003C 100,000 \u002F mm³)\n5. Severe, uncorrected coagulopathy (at the discretion of the physician)\n6. Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists\n7. Porphyria (clinician's assessment) or other light-exacerbated diseases\n8. Severely impaired liver and or kidney function (at the discretion of the physician)\n9. Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3)\n10. Planned surgical procedure within the next 30 days\n11. Concurrent eye disease that will require a slit lamp examination within the next 30 days\n12. Prior radiotherapy within the last four weeks\n13. Previous PDT or RFA\n14. Planned liver transplantation\n15. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial medication on contraception)\n16. Participation in other interventional trials\n17. Patients under legal supervision or guardianship\n18. Pregnant or nursing women",{"count":128,"type":21},258,[130],"PHASE4","Bile duct cancer is often diagnosed after curative options are no longer available. Stent therapy is used to keep the ducts open and can be combined with photodynamic therapy (PDT) to extend life expectancy. PDT requires an injection of photosensitizer after which light of a particular wavelength is applied endoscopically to kill the cancer cells. Drawbacks include not only high costs and poor availability, but foremost that patients have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA) together with stent implantation constitutes an alternative by which the cancer cells are killed through heat, also applied endoscopically. The RFA technology is more widely available and easier to deploy. However, it has not been studied extensively and no randomized trials exist comparing the two methods. This trial will compare survival in patients with a particular bile duct cancer depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.",[28],[28,134,135,136,137,29],"Radiofrequency ablation (RFA)","Photodynamic therapy (PDT)","Photosensitizer","Klatskin Tumor","2025-03-24",{"date":140,"type":47},"2025-03-27",{"date":142,"type":47},"2023-02-10",{"date":144,"type":21},"2028-04",{"name":146,"class":54},"University of Leipzig",20]