[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cholangiocarcinoma-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cholangiocarcinoma-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,71,102,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100608807","in-depth-characterisation-of-biliary-strictures-and-hepato-pancreato-biliary-focal-lesions-for-development-of-new-technologies-to-tackle-hepato-pancreato-biliary-cancers-100608807",false,"NCT07206355","In-Depth Characterisation of Biliary Strictures and Hepato-Pancreato-Biliary Focal Lesions for Development of New Technologies to Tackle Hepato-Pancreato-Biliary Cancers","Map HPB","Inclusion Criteria:\n\n* Aged 16 years and over\n* Ability to provide informed consent to participate in the study\n* Patients attending Nottingham University Hospitals NHS Trust (NUH) as part of standard clinical care for either:\n\n  * the diagnosis and treatment of suspected biliary stricture or any focal lesion in the Hepato-Pancreato-Biliary (HPB) tract (clinically \u002F radiologically) including liver or pancreatic lesion or pancreatic cyst\n  * surgical resection treatment of liver, pancreas, or gall bladder including Whipple Procedure (pancreaticoduodenectomy surgery), gall bladder resection (cholecystectomy), hepatic resection\n\nExclusion Criteria: No exclusion criteria","ALL","16 Years",{"count":19,"type":20},160,"ESTIMATED","5 Years","OBSERVATIONAL","Hepato-Pancreato-Biliary (HPB) cancers originating in the liver, bile ducts, pancreas, and gall bladder represent a rising global health challenge, with incidence doubling in the UK over the past decade. Cholangiocarcinoma (CCA) and pancreatic cancer are particularly aggressive, often detected late due to non-specific symptoms and difficulties in sampling or imaging. In the UK, CCA affects around 3,000 people annually, with only 13% surviving 3 years, while pancreatic cancer has a 5-year survival of 8.3%. Diagnosis is complicated by the anatomical narrowness of the bile duct and the similarity between malignant and benign strictures. Standard imaging often cannot distinguish between inflammation and cancer, while tissue sampling is challenging, paucicellular, and limited in sensitivity, necessitating repeated biopsies. Yet, accurate characterisation is critical as NICE now recommends targeted therapies (FGFR2, NTRK, MSI-H\u002FdMMR, IDH1 mutations) that require molecular profiling.\n\nBoth CCA and PDAC display high heterogeneity, further complicating treatment. Emerging approaches such as Raman spectroscopy can map malignant tissues by detecting vibrational energy shifts, but require further validation due to weak signals. For focal or cystic HPB lesions not well visualised by conventional imaging, novel modalities like ultra-thin endoscopes with scattering\u002Fabsorption imaging are being developed for improved early diagnosis.\n\nManagement of biliary obstruction frequently involves stenting to restore bile flow, essential for palliation and pre-treatment optimization. However, stent failure from tumour ingrowth, displacement, or erosion remains common, and evidence for best stent use is limited. Novel approaches, including drug-eluting coatings and nanoparticle-mediated wireless treatment delivery, are being investigated.\n\nTo overcome diagnostic and therapeutic barriers, flexible snake-like robotic systems with navigation, sampling, spectroscopy, and treatment capabilities are being developed. These devices, alongside ultra-thin endoscopes and integrated Raman spectroscopy, aim to characterise strictures, generate 3D imaging in ex-vivo HPB tissue, and permit targeted ablation. Parallel work will explore molecular and fluid-based biomarkers (blood, bile, cyst fluid) to support minimally invasive diagnosis and monitoring.\n\nThrough integration of engineering, molecular diagnostics, and device innovation, this transdisciplinary research programme (UKRI and MRC funded) seeks to transform early detection, accurate diagnosis, and novel treatment of HPB cancers, thereby improving outcomes in CCA, pancreatic malignancy, and other clinically similar biliary disorders.\n\nAim:\n\nTo provide a detailed understanding of the characteristics (including clinical and molecular) of liver and pancreatic biliary focal lesions (inflammatory and cancerous) and create a bioresource of liver, pancreas, gallbladder and biliary tract associated tissue and fluids (biopsies, brushings, resected tissues, bile and cyst fluid and blood samples) in order to develop innovative tools for accurate diagnosis and treatment.\n\nStudy Configuration: Prospective Longitudinal Cohort study Setting: Secondary care centre, Nottingham University Hospitals NHS Trust. (NUH).\n\nCo-ordinated by the NIHR Nottingham Biomedical Research Centre Description of interventions: This is an observational study involving collecting tissue or body fluids (such as bile or pancreatic cyst fluid) during clinical care in addition to collection of blood samples (for DNA, serum and plasma) and data collection.\n\nSurplus tissue residual to the requirements for standard care will be stored and used. Additional tissue samples and body fluid samples collected for research at time of clinical investigations will not be increasing the risk of the clinical procedure.\n\nBlood samples will be collected from patients at the time of enrolment in the study. These may be collected before and\u002F or after diagnosis is secured.\n\nDuration of study: Overall duration: 60 months Outcome measures: - To report the proportion of patients where adequate tissue could be retrieved from HPB biopsy to come to definitive diagnosis using standard of care.\n\n* To report the proportion of patients where adequate tissue could be retrieved from biopsy to perform molecular characterisation of HPB samples, beyond standard cyto\u002Fhistology, using advanced optical-spatial technologies currently under development.\n* To report the proportion of patients where definitive diagnosis of mucinous cystic neoplasm could be made in patients with pancreatic cyst using standard care\n* To report the proportion of patients where molecular characterisation beyond standard cyto\u002Fhistology could be made in patients with pancreatic cyst using exploratory new technologies under development through ex-vivo experiments\n* To report the correlation between Raman Spectroscopy and standard cyto\u002Fhistology for identification of cancer in HPB samples",[25,26,27,28,29,30,31],"Biliary Tract Cancer (BTC)","Biliary Tract Cancer (CCA)","Cholangiocarcinoma","Cholangiocarcinoma Cancer","Cholangio Carcinoma","Pancreatic Cancer","Pancreatic Cyst",[33,30,31,34,25,27],"biliary tract cancer","Pancreatic lesions","RECRUITING","2026-04-28",{"date":38,"type":39},"2026-04-29","ACTUAL",{"date":41,"type":39},"2026-01-25",{"date":43,"type":20},"2030-09-30",{"name":45,"class":46},"University of Nottingham","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100616146","clinical-application-of-pet-imaging-targeting-cldn182-in-malignant-tumors-100616146","NCT07301814","Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant Tumors","Inclusion Criteria:\n\n* Each participant must meet all inclusion criteria to be eligible to participate in the study:\n\n  1. The participant or their legal representative is able to sign the informed consent form with signature and date;\n  2. Commit to adhering to the research procedures and cooperating in the implementation of the entire research process;\n  3. Adult patients or healthy volunteers (aged 18-70 years), male or female;\n  4. Patients with malignant tumors such as gastric cancer, pancreatic cancer, bile duct cancer, esophageal cancer, etc., suspected or diagnosed clinically (supporting evidence includes serum tumor markers, ultrasound, CT, MRI, and other imaging data, as well as histopathological examination), and in good general condition;\n  5. Meet specific laboratory test results;\n  6. Women of childbearing age must use contraception for at least one month before screening and commit to using contraception throughout the study period and continuing it until the specified time after the study ends;\n  7. Other set inclusion criteria.\n\nExclusion Criteria:\n\n* All subjects who meet any exclusion criteria baseline will be excluded from the study:\n\n  1. Those unable to complete PET\u002FMR or PET\u002FCT scans (including those unable to lie flat, claustrophobia, radiation phobia, etc.);\n  2. Those with other comorbidities;\n  3. Patients known to be allergic to the targeted CLDN18.2 PET imaging agent or synthetic excipients; fasting blood glucose level exceeding 11.0 mmol\u002FL before injection of 18F-FDG;\n  4. Those with a history of concomitant medication use;\n  5. Patients considered to have poor compliance by the researcher.",true,"18 Years",{"count":57,"type":20},56,"The project aims to perform integrated PET\u002FMR or PET\u002FCT imaging in patients with histologically confirmed or clinically suspected gastric cancer, pancreatic cancer, cholangiocarcinoma, or other malignant tumors with high Claudin18.2 (CLDN18.2) expression, as well as healthy volunteers. This study utilizes a CLDN18.2-specific PET imaging probe (e.g., \\[\\^68Ga\\]Ga-labeled humanized antibody fragment) to evaluate the feasibility, accuracy, and clinical value of non-invasive, in vivo CLDN18.2 visualization.\n\nFor patients with malignant tumors, the study will assess the diagnostic performance of CLDN18.2-targeted PET in identifying tumor lesions, compare the imaging results with gold-standard histopathology, determine the location, extent, and metabolic features of CLDN18.2-positive lesions, and evaluate tumor burden and treatment stratification value compared with \\[\\^18F\\]FDG PET imaging. These results may assist in patient selection for CLDN18.2-targeted therapies (e.g., Zolbetuximab), guide clinical decision-making, and provide early prediction of therapeutic response.\n\nFor healthy volunteers, pharmacokinetic profiling will be conducted to investigate the biodistribution, clearance, and safety of the radiotracer in vivo.",[60,30,28,61],"Gastric Cancer","Esophageal Cancer","2025-12-11",{"date":64,"type":39},"2025-12-24",{"date":66,"type":39},"2025-09-01",{"date":68,"type":20},"2026-12-31",{"name":70,"class":46},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100562754","phase-2-phase-2-trial-of-adjuvant-adebrelimab-combined-with-capecitabine-in-high-risk-resected-cholangiocarcinoma-achieve-100562754","NCT06607276","Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE","A Phase 2, Randomized, Controlled, Multicenter Study of Adjuvant Adebrelimab Combined With Capecitabine in Resected Cholangiocarcinoma With High-risk Factors: ACHIEVE","ACHIEVE","Inclusion Criteria:\n\n1. Patients must sign an informed consent form;\n2. Ages 18-75, both genders eligible;\n3. ECOG performance status score (PS score) of 0 or 1;\n4. Patients with histologically confirmed cholangiocarcinoma (including intrahepatic cholangiocarcinoma and hilar cholangiocarcinoma), who have undergone R0 resection and have high-risk factors for recurrence;\n\n   High-risk factors are defined as follows:\n\n   Intrahepatic cholangiocarcinoma ( Single tumor \\> 5 cm, multiple tumors, liver capsule breach, vascular invasion, regional lymph node metastasis) Hilar cholangiocarcinoma (Tumor invasion into surrounding tissues, vascular invasion, regional lymph node metastasis)\n5. No evidence of recurrence or metastatic lesions on imaging within 28 days prior to randomization;\n6. No prior systemic anti-cancer therapy (including radiotherapy, chemotherapy, targeted therapy, immunotherapy) before curative resection;\n7. Laboratory test values within 7 days prior to the first dose of study medication meet the following criteria:\n\n   Complete blood count: (except for hemoglobin, no blood transfusion or use of granulocyte colony-stimulating factor \\[G-CSF\\], no medication correction within 2 weeks prior to screening):\n\n   Absolute neutrophil count ≥1.5×109\u002FL; Platelets ≥75×109\u002FL; Hemoglobin ≥90 g\u002FL;\n\n   Biochemical tests:\n\n   Serum albumin ≥30g\u002FL; Serum total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN; Serum creatinine ≤1.5×ULN; or Cr clearance rate \\>50 mL\u002Fmin International normalized ratio (INR) ≤1.2 or prothrombin time (PT) exceeding the normal control range by ≤2 seconds; Urine protein \\<2+ (if urine protein ≥2+, a 24-hour (h) urine protein quantification can be performed, and a 24h urine protein quantification of \\<1.0g is eligible for enrollment);\n8. Life expectancy of more than 6 months.\n\nExclusion Criteria:\n\n1. Pathological diagnosis of mixed hepatocellular carcinoma and other non-hepatic extra-bile duct cholangiocarcinoma or ampulla of Vater malignant tumor components;\n2. History of prior systemic treatment;\n3. History of or concurrent other malignancies, excluding non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma that have been adequately treated;\n4. Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; history of active tuberculosis infection more than 1 year prior to enrollment without proper anti-tuberculosis treatment or tuberculosis is still active;\n5. History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener\\'s granulomatosis, Sjogren\\'s syndrome, Guillain-Barre syndrome, or multiple sclerosis;\n6. Requirement for long-term systemic corticosteroids (dosage equivalent to \\>10mg prednisone\u002Fday) or any other form of immunosuppressive treatment. Subjects using inhaled or topical corticosteroids may be included;\n7. Severe cardiopulmonary or renal dysfunction;\n8. Inadequately controlled arterial hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) (based on the average of ≥2 blood pressure readings), allowing the achievement of the above parameters through the use of antihypertensive treatment; history of hypertensive crisis or hypertensive encephalopathy;\n9. Within 3 months prior to enrollment, significant clinical bleeding symptoms or a clear tendency to bleed; abnormal coagulation function (PT \\>14s), tendency to bleed, or undergoing thrombolytic or anticoagulant therapy;\n10. HBV DNA \\>2000 IU\u002Fml, active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection);\n11. Active infection requiring systemic treatment;\n12. Human immunodeficiency virus (HIV, HIV1\u002F2 antibody) positive;\n13. History of psychiatric medication abuse, alcoholism, or drug addiction;\n14. History of allergy to study medication;\n15. Other factors deemed by the investigator to potentially affect subject safety or trial compliance. Such as severe diseases requiring concurrent treatment (including psychiatric diseases), severe laboratory test abnormalities, or other family or social factors.","75 Years",{"count":81,"type":20},122,"INTERVENTIONAL",[84],"PHASE2","Biliary tract malignancies (BTC) are malignant tumors that originate from the epithelium of the bile ducts. Currently, the optimal treatment for biliary tract malignancies is radical surgical resection. In recent years, with the advancement of imaging technology and surgical techniques, there has been certain progress in the diagnosis and treatment of biliary tract malignancies. However, the surgical resection rate and long-term survival rate after surgery are still not satisfactory, and the high postoperative recurrence rate is an important factor affecting the long-term survival of patients. Therefore, there is an urgent need to explore new postoperative adjuvant treatment plans to reduce postoperative tumor recurrence, which is of great significance for extending the survival of patients with biliary tract malignancies. In the NCCN and CSCO guidelines, capecitabine is listed as a category I recommendation for adjuvant treatment of biliary tract malignancies (BTC). However, in clinical practice, the use of capecitabine or tegafur for postoperative patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate. Therefore, there is still a huge unmet need in the clinical adjuvant treatment after surgery for biliary tract malignancies. Based on the above background, we plan to carry out a randomized, open, and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery, and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma.",[28,87],"Adebrelimab (SHR-1316)",[89,90,27,91],"Adebrelimab","capecitabine","Adjuvant Therapy","2025-01-14",{"date":94,"type":39},"2025-01-16",{"date":96,"type":39},"2024-09-20",{"date":98,"type":20},"2027-09-20",{"name":100,"class":46},"The First Affiliated Hospital with Nanjing Medical University",4,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":22,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":47},"100575623","intra-artherial-therapies-in-treatment-of-primary-liver-diseases-an-observational-study-100575623","NCT06774690","Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study","Inclusion Criteria:\n\n* diagnosis of Hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA) and clinical indication to receive or have already received one of the following treatments:\n\n  * Trans-arterial embolization (TAE),\n  * Transarterial chemoembolization (TACE),\n  * Transarterial radioembolization (TARE)\n  * Drug-eluting beads chemoembolization (DEB-TACE)\n* Age over 18\n* To give informed consent\n\nExclusion Criteria:\n\n* shunt of gastro intestinal arteries that cannot be embolized\n* metastasis spread outside of the liver\n* liver failure",{"count":109,"type":20},3300,"9 Years","The goal of this observational study is to learn what are the best conditions that will give a positive outcome to men and women that receive a intra arterial therapy (IAT) for primary liver cancer.\n\nIntra arterial therapies are radiologic procedures that block liver cancer blood supply.\n\nThe researchers will collect the data of participants located in the Radiology department in \"IRCCS Azienda Ospedaliera Universitaria\" Hospital in Bologna and will study clinic and radiological traits to understand which is the best case scenario for a optimal treatment response.",[113,28],"HCC - Hepatocellular Carcinoma","2025-01-09",{"date":92,"type":39},{"date":117,"type":39},"2021-04-21",{"date":119,"type":20},"2030-04",{"name":121,"class":46},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":129,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":47},"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":130,"type":20},32,"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).",[28,133],"Perihilar Cholangiocarcinoma",[135,136,137,138,139,140],"cholangiocarcinoma","robot","robotic","perihilar","cca","phc","2024-12-05",{"date":143,"type":39},"2024-12-06",{"date":145,"type":39},"2024-06-07",{"date":147,"type":20},"2031-07-07",{"name":149,"class":46},"Azienda Ospedaliera di Padova"]