[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cholangiocarcinoma-intrahepatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cholangiocarcinoma-intrahepatic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100639462","phase-1-safety-and-efficacy-of-cd160-enhanced-autologous-antigen-specific-t-cells-btc-ag-t-in-advanced-biliary-tract-cancer-100639462",false,"NCT07614061","Safety and Efficacy of CD160-Enhanced Autologous Antigen-Specific T-Cells (BTC-Ag-T) in Advanced Biliary Tract Cancer","A Phase I, Open-label Study to Evaluate the Safety and Efficacy of CD160-enhanced Autologous BTC-Ag-T Cells in Advanced Biliary Tract Malignancies","Major Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1\\. Age\n\n\\- Age ≥ 18 years at the time of signing informed consent. 2. Diagnosis\n\n* Histologically or cytologically confirmed biliary tract malignancy (intrahepatic, perihilar, or distal extrahepatic cholangiocarcinoma, or gallbladder cancer).\n\n  3\\. Disease status\n* Locally advanced unresectable or metastatic disease 4. Prior systemic therapy\n* Patients (including those with refractory BTC and those with postoperative recurrence) must have received prior gemcitabine-based chemotherapy in combination with a PD-1\u002FPD-L1 inhibitor.\n\n  5\\. Measurable disease\n* At least one measurable lesion per RECIST v1.1 at baseline imaging.\n* Sufficient viable tumor tissue from biopsy for antigen-presenting tumor cell (APTC) manufacturing 6. Adequate venous access and overall condition to tolerate leukapheresis. 7. Washout and lymphocyte recovery before leukapheresis 8. ECOG performance status 0 or 1 9. Organ function\n* Hematology (no growth-factor support or transfusion within 5 days of testing, unless otherwise stated): ANC ≥ 1.0 × 10⁹\u002FL; platelets ≥ 75 × 10⁹\u002FL; hemoglobin ≥ 8.0 g\u002FdL (transfusion to reach this threshold is permitted).\n* Hepatic: total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for documented Gilbert syndrome); AST and ALT ≤ 5.0 × ULN.\n* Renal: serum creatinine ≤ 1.5 × ULN, or estimated creatinine clearance (e.g., Cockcroft-Gault) ≥ 40 mL\u002Fmin.\n* Adequate cardiopulmonary reserve to tolerate lymphodepleting conditioning and cell infusion in the investigator's judgment.\n\n  10\\. Viral serology\n* No evidence of uncontrolled active viral infection.\n* HIV-1\u002F2 negative.\n* Hepatitis B: HBV DNA is negative.\n* Hepatitis C: HCV RNA is negative. 11. Contraception\n* Women of childbearing potential and men whose partners are of childbearing potential must agree to use highly effective contraception from the time of informed consent through at least 12 months after BTC-Ag-T infusion (or longer if required by local regulation).\n\n  12\\. Pregnancy status\n* Women of childbearing potential must have a negative serum or urine pregnancy test at screening.\n\n  13\\. Informed consent\n* Able to understand and willing to sign a written informed consent document, and willing to comply with study procedures.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded:\n\n1. Mixed\u002Fcombined hepatocellular-cholangiocarcinoma, ampullary carcinoma, and other histologies not consistent with BTC\n2. Prior allogeneic transplant or recent gene-modified cell therapy\n3. Active CNS metastases\n4. Patients with uncontrolled or high-risk active infection are excluded, including hepatitis B virus (HBV), hepatitis C virus (HCV), Epstein-Barr virus (EBV), and active tuberculosis (TB).\n5. Active autoimmune disease requiring systemic immunosuppression\n6. Significant cardiovascular disease\n7. Significant pulmonary disease\n8. Severe hepatic decompensation\n9. Active variceal bleeding, or recent life-threatening portal-hypertension complications that cannot be stably controlled.\n10. Another primary malignancy within the past 3 years, except: tumors treated with curative intent and at low risk of recurrence (e.g., adequately treated basal- or squamous-cell skin cancer, in-situ cervical cancer, or low-Gleason localized prostate cancer, occult thyroid carcinoma).\n11. Severe hypersensitivity.\n12. Pregnant or lactating women\n13. Concurrent participation in another interventional study\n14. Any other condition that, in the investigator's judgment, renders the patient unsuitable for enrollment.","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","BTC-Ag-T (ACH-AgT001) is an autologous experimental T-cell therapy designed for advanced biliary tract cancer. This is an open-label, single-arm Phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of BTC-Ag-T in patients with advanced, unresectable, or metastatic biliary tract cancer who have failed standard-of-care therapy.",[26,27,28,29,30],"Biliary Tract Neoplasms","Cholangiocarcinoma, Intrahepatic","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Perihilar","Gallbladder Cancer",[32,33,34,35,36,37,38,39,40,41],"Adoptive T-cell therapy","Antigen-specific T cells","CD160","Autologous T cell therapy","Biliary tract cancer","Cholangiocarcinoma","APTC - antigen-presenting tumor cell","Lymphodepletion","Phase 1","Investigator-initiated trial","RECRUITING","2026-05-28",{"date":45,"type":46},"2026-05-29","ACTUAL",{"date":48,"type":20},"2026-05",{"date":50,"type":20},"2029-12",{"name":52,"class":53},"Shanghai Zhongshan Hospital","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":62,"enrollmentInfo":63,"targetDuration":65,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100526852","liver-transplantation-in-intrahepatic-cholangiocarcinoma-100526852","NCT06140134","Liver Transplantation in Intrahepatic Cholangiocarcinoma","A Single-Arm Nonrandomized Phase II Study of Liver Transplantation in Locally Advanced Unresectable Non-Metastatic Intrahepatic Cholangiocarcinoma Treated With Neoadjuvant Systemic Therapy","Inclusion Criteria:\n\n* Age ≥18 years of age on the day of consenting to the study.\n* Patients must have histologically confirmed diagnosis of locally advanced intrahepatic cholangiocarcinoma\n* Confirmed diagnosis of locally advanced unresectable iCCA with no vascular invasion, lymph node, or extrahepatic disease.\n* Unresectable disease based on tumor location or underlying liver disease\n* Patients must have ≥ 6 months of disease stability or tumor regression on neoadjuvant therapy. In cases in which patients had received second-line therapy, disease must also have been controlled for ≥ 6 months on that regimen.\n* Patients who had previous surgical resection for iCCA are eligible if surgery occurred more than 6 months prior to listing, and patients have had ≥ 6 months of disease stability or response on therapy.\n* ECOG performance status ≤1 (Karnofsky ≥70%, see Appendix A).\n* Patients must have organ and marrow function acceptable for liver transplantation per institutional protocol:\n* If history of chronic hepatitis B virus (HBV) infection, viral load should be undetectable on suppressive therapy.\n* If history of chronic hepatitis C virus (HCV) infection, patients should have undetectable HCV viral load.\n* Women of child-bearing years must have contraception plan in place from the time of study enrollment until at least one year following liver transplant.\n* Ability to understand and the willingness to sign a written informed consent document\n* Meets all other medical and psychosocial criteria for liver transplant\n* Demonstrate ability to comply with study procedures\n\nExclusion Criteria:\n\n* Age \\\u003C18 years of age on the day of consenting to the study.\n* Patients who have extrahepatic metastases, lymph node involvement, invasion or encasement of major hepatic vascular structures, perforation of the visceral peritoneum, invasion of extrahepatic structures, invasion of perihilar fat, periductular invasion, concurrent hepatoma or mixed hepatocellular cholangiocarcinoma.\n* Concurrent severe and\u002For uncontrolled concurrent illness including, but not limited to, ongoing or active infection, acute fulminant liver failure, symptomatic congestive heart failure, unstable angina pectoris, severe uncorrected coronary artery disease, severe cerebrovascular disease, severe pulmonary disease, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements and that would exclude the patient from eligibility for liver transplantation per institutional protocol.\n* Prior solid organ or bone marrow transplant\n* Dependent on ≥2 IV inotropic support to maintain hemodynamics\n* Previous (within the past 5 years) or concurrent presence of other cancer, except non-melanoma skin cancer and in situ carcinomas.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score \\>1 (Karnofsky \\\u003C70%, see Appendix A).\n* Unable to understand and sign a written informed consent document\n* Untreated viral hepatitis\n* Pregnant or breast-feeding women\n* HIV-infected patients","89 Years",{"count":64,"type":20},30,"5 Years","OBSERVATIONAL","The aim of the current study is to determine the potential efficacy of liver transplantation in the form of patients' overall survival (OS) after neoadjuvant systemic therapy in patients with biologically responsive locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) in comparison to patients historically treated with chemotherapy alone.",[69,27],"Intrahepatic Cholangiocarcinoma",[71,72,73,74,75,76,77,78,79],"liver transplantation","neoadjuvant systemic therapy","intrahepatic cholangiocarcinoma","iCCA","locally advanced non-metastatic iCCA","non-metastatic intrahepatic cholangiocarcinoma","liver transplant","unresectable intrahepatic cholangiocarcinoma","locally advanced intrahepatic cholangiocarcinoma","2026-03-18",{"date":82,"type":46},"2026-03-20",{"date":84,"type":46},"2023-12-15",{"date":86,"type":20},"2029-11",{"name":88,"class":53},"Rutgers, The State University of New Jersey",2,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":65,"studyType":66,"phases":4,"briefSummary":99,"conditions":100,"keywords":111,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":54},"100627888","trace-btc-relation-of-biomarkers-and-patients-reported-quality-of-life-to-outcomes-in-patients-with-biliary-tract-cancer-a-real--world-cohort-100627888","NCT07454486","TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort","TRACE-BTC","Inclusion Criteria:\n\n* Histopathologically verified biliary tract cancer (BTC) and\u002For Multidisciplinary Team (MDT) conference decision to define the patient as suffering from BTC.\n* Eligible for curative, adjuvant, or palliative oncological treatment.\n* Age ≥ 18 years.\n* Written and oral consent.\n\nExclusion Criteria:\n\n* Other malignant diseases within 5 years of BTC diagnosis, excluding early-stage non-melanoma skin cancer and carcinoma in situ of the cervix.\n* Conditions that prohibit blood sampling.\n* Known or suspected non-compliance.",{"count":98,"type":20},300,"Purpose of the Study:\n\nBile duct cancers are rare and aggressive. About 250 new cases are diagnosed each year in Denmark. These cancers are difficult to detect early, so only about 20% of patients can have surgery when diagnosed. Even after surgery, the cancer often returns, and chemotherapy only slightly reduces the risk of relapse.\n\nFor patients who cannot have surgery, treatments such as chemotherapy (sometimes combined with immunotherapy) can relieve symptoms and extend life, but their effect is limited. A small number of patients have specific genetic changes in their cancer that can be treated with targeted medicines.\n\nCurrently, doctors cannot predict which patients will benefit from treatment. Standard monitoring methods like CT scans are expensive, inconvenient, and sometimes unreliable because bile ducts are hard to see clearly on scans.\n\nBlood tests that detect cancer DNA in the blood (called circulating tumor DNA or ctDNA) and other biological markers may be a better way to monitor the disease and adjust treatment. These tests could help detect cancer recurrence earlier and determine whether treatment is working. Measuring patients' quality of life and symptoms over time may also help predict treatment benefit and evaluate effectiveness.\n\nThe goal of this study is to:\n\n* Investigate how biomarkers, including ctDNA, can predict disease course, detect relapse, and monitor treatment response.\n* Identify the best way to measure ctDNA in patients with bile duct cancer.\n* Examine whether patients' own reports of quality of life and symptoms can help assess treatment effect and prognosis.\n\nStudy Design and Procedures:\n\nThis is a prospective cohort study focusing on blood biomarkers and patient-reported symptoms and quality of life.\n\nParticipants agree to provide blood samples:\n\n* Before treatment\n* During treatment\n* During follow-up\n\nEach sample involves up to 40 ml of blood, with a maximum of 20 samples per patient.\n\nThe blood will be analyzed for:\n\n* ctDNA and genetic changes\n* Cancer-related markers\n* Inflammation markers\n* Immune system markers\n\nTumor tissue samples will also be examined to compare blood and tissue results. Full genome or exome sequencing will not be performed. Samples will be stored in a research biobank.\n\nFor patients with incurable disease, quality of life and symptom burden will be monitored repeatedly using Danish questionnaires.\n\nParticipants:\n\nThe study will include:\n\n* Up to 100 patients with potentially curable disease\n* Up to 200 patients with incurable disease\n\nTo participate, patients must:\n\n* Have confirmed bile duct cancer\n* Be eligible for curative, additional (adjuvant), or palliative treatment\n* Be over 18 years old\n* Provide written and verbal consent\n\nPatients cannot participate if they:\n\n* Had another cancer within the past 5 years (except early skin cancer or very early cervical cancer)\n* Cannot safely provide blood samples\n* Are unable to cooperate with study procedures\n\nRisks and Inconveniences:\n\nParticipants will have extra blood samples taken, usually during regular hospital visits. Possible side effects include mild soreness or small bruises at the needle site. The extra blood amount (40 ml per sample) is considered medically insignificant.\n\nParticipants will also spend time filling out questionnaires. The number and frequency of questions have been kept as low as possible while still providing meaningful data.\n\nFinancial Information:\n\nExtra costs for blood sampling, laboratory analysis, and data collection will be covered by external research funding managed by Aarhus University Hospital.\n\nThe researchers have no financial interest in the project. Patients will not receive financial compensation for participating.\n\nRecruitment and Consent:\n\nPotential participants are identified during routine clinical care. During a planned meeting with a doctor, patients receive written and verbal information about the study, including its purpose, risks, advantages, and disadvantages.\n\nThe conversation takes place in a calm and private setting. Patients may bring a support person. They have time to ask questions and at least 24 hours to consider participation.\n\nPatients can withdraw their consent at any time without affecting their treatment. Consent must be given before any study-related procedures begin.\n\nPublication of Results:\n\nThe results - whether positive or negative - will be presented at national and international conferences and submitted to peer-reviewed scientific journals.\n\nEthical Considerations:\n\nAll participants receive standard medical treatment. The risks and disadvantages are limited, and participants are unlikely to benefit directly from the study. However, the research may improve how biomarkers and patient-reported outcomes are used to predict prognosis and treatment response, potentially leading to better treatment for future patients with bile duct cancer.",[101,102,103,104,37,105,106,107,108,28,109,27,29,110],"Biliary Tract Cancer (BTC)","Biliary Tract Cancer (CCA)","Gall Bladder Cancer","Biliary Tract Cancers (BTC)","Cholangiocarcinoma Non-resectable","Cholangiocarcinoma Resectable","Cholangiocarcinoma Metastatic","Cholangiocarcinoma of the Bile Duct","Cholangiocarcinoma, Hilar","Cholangiocarcinoma; Liver",[26,37,69,112,113,114,115,116,117,118,119,120,121],"Extrahepatic Cholangiocarcinoma","Gallbladder Neoplasms","Circulating Tumor DNA","Liquid Biopsy","Minimal Residual Disease","Biomarkers, Tumor","Observational Study","Biobanking","DNA Methylation","Precision Oncology","NOT_YET_RECRUITING","2026-03-02",{"date":125,"type":46},"2026-03-06",{"date":127,"type":20},"2026-03-15",{"date":129,"type":20},"2031-12-30",{"name":131,"class":53},"Aarhus University Hospital"]