[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-tract-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-tract-neoplasms":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,48,72,111,148,171,197,278,311,332,360,384,404,422,451,471],{"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":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":4,"leadSponsor":44,"locationsCount":47},"100205406","tissue-procurement-and-natural-history-study-of-patients-with-malignant-mesothelioma-100205406",false,"NCT01950572","Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma","Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma and Other Mesothelin Expressing Cancers","* INCLUSION CRITERIA:\n* All participants \\>= 2 years of age with malignant mesothelioma.\n* All participants \\>=18 years of age with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin.\n* Confirmed pathological diagnosis is required\n* Ability and willingness of participant to provide informed consent to participation.\n\nEXCLUSION CRITERIA:\n\n* Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.\n* Pregnant women.\n* Active concomitant medical or psychological illnesses that may increase the risk to the participant or in adult participants, inability to obtain informed consent, at the discretion of the principal investigator.","ALL","2 Years","100 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","Background:\n\n* Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis.\n* Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States.\n* The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis.\n* Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease.\n* In addition to mesothelioma, mesothelin is highly expressed in several cancers, including pancreatic, biliary adenocarcinomas, gastric and ovarian cancers; mesothelin is also expressed in a significantly larger proportion of thymic carcinoma than thymoma.\n\nObjectives:\n\n-To allow sample acquisition for use in the study of mesothelioma.\n\nEligibility:\n\n* All participants age greater than or equal to 2 years with malignant mesothelioma OR\n* All participants greater than or equal to 18 years with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin\n* Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18\n\nDesign:\n\n* Up to 1000 subjects will be enrolled.\n* Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma.\n* Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking.\n* Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.",[25,26,27,28,29,30],"Thymoma","Stomach Neoplasms","Pancreatic Neoplasms","Mesothelioma","Biliary Tract Neoplasms","Mesothelin Expressing Neoplasms",[32,33,34,35,36],"Samples","Biobank","Lung Neoplasms","Ovarian Neoplasms","Natural History","RECRUITING","2026-06-24",{"date":40,"type":41},"2026-06-25","ACTUAL",{"date":43,"type":41},"2013-09-09",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100643984","phase-2-an-open-label-single-arm-multicenter-exploratory-study-of-adebrelimab-combined-with-gemcitabine-and-albumin-bound-paclitaxel-as-first-line-treatment-for-biliary-tract-malignancies-100643984","NCT07668453","An Open-label, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Gemcitabine and Albumin-bound Paclitaxel as First-line Treatment for Biliary Tract Malignancies","Inclusion Criteria:\n\n* Age 18 to 75 years, male or female. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. No prior local or systemic treatment for biliary tract malignancy. Histologically or cytologically confirmed initially unresectable or inoperable biliary tract cancer; recurrent biliary tract tumor after surgery; or patients who received post-operative adjuvant therapy must have been off treatment for more than 6 months. Adequate organ and hematological function. Life expectancy of ≥ 3 months. Laboratory results within 7 days prior to the first dose meeting the following criteria:Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, Platelets ≥ 75 × 10\\^9\u002FL, Hemoglobin ≥ 90 g\u002FL (without blood transfusion or G-CSF within 2 weeks prior to screening); Serum albumin ≥ 30 g\u002FL, Total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Serum creatinine ≤ 1.5 × ULN or Creatinine clearance \\> 50 mL\u002Fmin; INR ≤ 1.2 or PT exceeding the normal control range by ≤ 2 seconds; Urine protein \\\u003C 2+ (if ≥ 2+, 24-hour urine protein quantification must be \\\u003C 1.0 g). Women of childbearing potential must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must not be lactating. Male subjects with female partners of childbearing potential must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug, and must not donate sperm during this period.\n\nExclusion Criteria:\n\n* Pathological diagnosis of mixed hepatocellular carcinoma or containing other non-cholangiocarcinoma malignant components. Prior systemic therapy. History of or concurrent other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid cancer. Active pulmonary tuberculosis infection within 1 year prior to enrollment; or history of active tuberculosis infection over 1 year ago without formal anti-tuberculosis treatment or with tuberculosis still in the active phase. 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 syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis. Requiring long-term systemic corticosteroid therapy (dose equivalent to \\> 10 mg\u002Fday prednisone) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are allowed. Severe cardiopulmonary or renal dysfunction. Uncontrolled arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); history of hypertensive crisis or hypertensive encephalopathy. HBV DNA \\> 2000 IU\u002Fml, or active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection). Active infection requiring systemic therapy. Human immunodeficiency virus (HIV 1\u002F2 antibody) positive. History of psychotropic drug abuse, alcoholism, or drug addiction. History of allergy to study drugs. Other factors that, in the judgment of the investigator, may affect the safety of the subject or compliance with the trial","18 Years","75 Years",{"count":57,"type":21},30,"INTERVENTIONAL",[60],"PHASE2","The purpose of this clinical trial is to evaluate the safety and effectiveness of a new combination therapy for patients with biliary tract cancer that cannot be removed by surgery. Participants will receive an immunotherapy drug called adebrelimab combined with two chemotherapy drugs (gemcitabine and albumin-bound paclitaxel) as their first-line treatment. This is an open-label, single-arm study, meaning all enrolled patients will receive this same combination treatment. The main goal of the study is to determine the Objective Response Rate (ORR), which measures the proportion of patients whose tumors shrink in response to the treatment. Researchers will also evaluate how long patients live without the disease getting worse (Progression-Free Survival), overall survival, quality of life, and any side effects experienced. The study plans to enroll 30 participants.",[29],"2026-06-22",{"date":40,"type":41},{"date":66,"type":41},"2025-10-20",{"date":68,"type":21},"2027-12-31",{"name":70,"class":71},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":58,"phases":80,"briefSummary":81,"conditions":82,"keywords":97,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100643697","phase-2-exploratory-study-on-the-efficacy-and-safety-of-trastuzumab-rezetecan-in-the-treatment-of-her2-expressiong-advanced-solid-tumor-100643697","NCT07631884","Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor","Inclusion Criteria:\n\n1. Male and female participants aged 18 years or older.\n2. Participants with locally advanced, unresectable or metastatic solid tumors who have progressed after at least one prior systemic therapy for advanced\u002Fmetastatic disease, or have no satisfactory alternative treatment options. Eligible tumor types include but are not limited to biliary tract cancer, endometrial cancer, urothelial carcinoma, pancreatic cancer, colorectal cancer, gastric cancer, non-small cell lung cancer, head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary in the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Breast cancer is excluded.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n4. Confirmed HER2 expression defined as IHC 1+, 2+ or 3+ (per GC criteria).\n5. Willing and able to provide adequate tumor specimens for central pathological re-testing of HER2 status. For participants previously treated with anti-HER2 therapy, tumor specimens obtained after the last anti-HER2 treatment are optional.\n6. At least one measurable lesion at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Adequate organ and bone marrow function within 14 days prior to enrollment, meeting the following criteria:\n\n   Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 100,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1500\u002Fmm³; Serum albumin ≥ 3.0 g\u002FdL; Prothrombin time (PT), activated partial thromboplastin time (aPTT) and International Normalized Ratio (INR) ≤ 1.5 × upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN; ≤ 5 × ULN for participants with liver metastases; Total bilirubin ≤ 1.5 × ULN for participants without liver metastases; ≤ 3 × ULN for participants with Gilbert's syndrome or liver metastases at baseline; Creatinine clearance ≥ 30 mL\u002Fmin (calculated by the Cockcroft-Gault formula)\n8. Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days prior to enrollment.\n\nExclusion Criteria:\n\nParticipants meeting any of the following conditions are ineligible for this study:\n\n1. Presence of any severe and\u002For uncontrolled diseases:\n\n   * Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL).\n   * Grade ≥ 2 myocardial ischemia, myocardial infarction, arrhythmia (QTc interval ≥ 470 ms), or Grade ≥ 2 congestive heart failure (per New York Heart Association \\[NYHA\\] classification).\n   * Active or uncontrolled severe infections (Grade ≥ 2 per NCI CTCAE) requiring systemic antibacterial, antifungal or antiviral therapy, including pulmonary tuberculosis.\n   * History of active tuberculosis.\n   * Uncontrolled ascites, pericardial effusion or pleural effusion requiring repeated drainage.\n2. Active hepatitis: Liver function not meeting the inclusion criteria. Hepatitis B: HBV DNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL.Hepatitis C: HCV RNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL. Participants with viral load below the above thresholds after nucleoside antiviral therapy are eligible. Chronic hepatitis B virus carriers with HBV DNA \\\u003C 10\\^4 IU\u002FmL must receive concurrent antiviral treatment throughout the study for enrollment.\n3. History of immunodeficiency diseases, including HIV positivity or other acquired\u002Fcongenital immunodeficiency disorders.\n4. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n5. Confirmed meningeal metastasis, spinal cord metastasis or spinal cord compression.\n6. Within 6 months prior to the first study drug administration, presence of esophageal gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive intestinal resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or long-standing chronic diarrhea.\n7. Unhealed or poorly healing wounds, or active ulcers.\n8. Toxicities from prior anti-tumor therapy have not resolved to Grade 0 or 1 per NCI CTCAE version 5.0.\n9. Received major surgery, incisional biopsy or significant traumatic injury within 28 days before study treatment initiation; or with long-standing unhealed wounds or fractures.\n10. History of severe hypersensitivity reactions to monoclonal antibodies; known allergy to the active ingredients or excipients of the study drug.",{"count":79,"type":21},15,[60],"The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants.\n\nThe main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg\u002Fkg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.",[83,84,85,86,87,88,89,29,90,91,27,92,93,94,95,96],"Solid Tumors","Neoplasms (Cancer \u002F Tumors)","Advanced Malignant Solid Neoplasm","Locally Advanced Malignant Solid Neoplasm","Unresectable Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm","HER2 Expression","Endometrial Neoplasms","Urothelial Carcinoma (UC)","Colorectal Neoplasms","Gastric Neoplasms","Non-Small Cell Lung Carcinoma (NSCLC)","Head and Neck Neoplasms","Cervical Neoplasms",[98,99,100],"HER2 expression","Trastuzumab Rezetecan","Advanced Solid Tumor","NOT_YET_RECRUITING","2026-06-02",{"date":104,"type":41},"2026-06-08",{"date":106,"type":21},"2026-06-15",{"date":108,"type":21},"2028-12-31",{"name":110,"class":71},"Haihua Yuan",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":58,"phases":120,"briefSummary":122,"conditions":123,"keywords":128,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":47},"100639462","phase-1-safety-and-efficacy-of-cd160-enhanced-autologous-antigen-specific-t-cells-btc-ag-t-in-advanced-biliary-tract-cancer-100639462","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.",{"count":119,"type":21},18,[121],"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.",[29,124,125,126,127],"Cholangiocarcinoma, Intrahepatic","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Perihilar","Gallbladder Cancer",[129,130,131,132,133,134,135,136,137,138],"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","2026-05-28",{"date":141,"type":41},"2026-05-29",{"date":143,"type":21},"2026-05",{"date":145,"type":21},"2029-12",{"name":147,"class":71},"Shanghai Zhongshan Hospital",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":58,"phases":157,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":167,"leadSponsor":169,"locationsCount":47},"100639337","scheduled-meditation-for-improving-postoperative-outcomes-in-patients-undergoing-pancreatectomy-100639337","NCT07608458","Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy","Scheduled Meditation for Perioperative Optimization: A Randomized Controlled Trial on Postoperative Outcomes, Pain, Anxiety, Insomnia, Stress, and Mobility in Pancreatectomy Patients","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Willing to install required apps on personal smartphone\n* Willing to wear a Garmin wearable device throughout the study\n* Age: ≥ 18 years\n* Ability to read and understand English for questionnaires\n* Owns a smartphone\n* Comfortable with routine smartphone use\n* Scheduled to undergo pancreatectomy\n\nExclusion Criteria:\n\n* Participants with prior formal training in meditation or mindfulness (e.g., completion of structured courses, workshops, or certification programs)\n* Participants who currently engage in a structured meditation or mindfulness practice, including regular use of mobile applications (e.g., Headspace, Calm, or similar platforms) or other formalized routines",{"count":156,"type":21},70,[158],"NA","This clinical trial tests the feasibility and how well a scheduled meditation intervention works to improve postoperative outcomes such as pain, anxiety, insomnia, stress and mobility for patients undergoing pancreatectomy. Many patients undergoing pancreatectomy surgery report clinically important fatigue, pain, and\u002For reduction in quality of life. Meditation is a behavioral intervention that has been studied in a variety of medical and surgical settings, where it has been associated with reductions in pain, anxiety, blood pressure, and lack of sleep, and in some cases with decreased pain and shorter length of stay. The meditation intervention using Headspace is an easily accessible and interactive way to complete scheduled meditation. This may improve postoperative outcomes for patients undergoing pancreatectomy.",[161,162,29],"Hepatocellular Carcinoma","Pancreas Cancer","2026-05-19",{"date":165,"type":41},"2026-05-27",{"date":40,"type":21},{"date":168,"type":21},"2026-11-25",{"name":170,"class":71},"City of Hope Medical Center",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":58,"phases":181,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100486572","phase-3-personalized-medicine-for-advanced-biliary-cancer-patients-100486572","NCT05615818","Personalized Medicine for Advanced Biliary Cancer Patients","Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial","SAFIR-ABC10","SCREENING PHASE\n\nInclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures (Consent #1)\n2. Histologically-proven intrahepatic, perihilar or distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded)\n3. De novo or recurrent, locally advanced (non-resectable) or metastatic disease\n4. Availability of a suitable archived sample of primary or metastatic tumour tissue (frozen, or FFPE) or able to undergo a biopsy to obtain a suitable malignant tissue sample\n5. Aged ≥18 years\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Estimated life expectancy \\>3 months\n8. Candidate for 1L-SoC therapy, or has initiated first cycle of 1L-SoC therapy\n9. Affiliated to a social security system or in possession of equivalent private health insurance (according to local country health provision arrangements).\n\nExclusion Criteria:\n\n1. Contraindication to 1L-SoC\n2. Patients who are candidates for locoregional therapy\n3. Contraindication to tumour biopsy in the absence of suitable archived sample of tumour tissue\n4. Prior anticancer therapy in the palliative setting. Adjuvant capecitabine allowed if completed ≥ 183 days prior to study entry\n5. Received more than 1 cycle of treatment with 1L-SoC\n6. Prior treatment with any of the MTT under investigation in the SAFIR-ABC10 study\n7. Current malignancies (other than ABC), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years or more and are deemed at negligible risk for recurrence, are eligible for the trial\n8. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol\n9. Women who are pregnant or breast-feeding\n10. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons\n11. Individuals deprived of liberty or placed under protective custody or guardianship\n\nRANDOMISED TRIAL\n\nInclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures (Consent #2)\n2. Molecular profile showing the tumour harbours at least one targetable molecular alteration with a MTT in the study portfolio (as determined by the trial MTB)\n3. Disease control (stable or responsive) after 4 cycles of 1L-SoC, compared to a pre-treatment disease evaluation, as assessed by the investigator\n4. ECOG performance status of 0 or 1\n5. Presence of at least one evaluable lesion according to RECIST v1.1, or complete response to 12 weeks 1L-SoC\n6. Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, and haemoglobin ≥9 g\u002FdL\n7. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (total bilirubin ≤3.0 ULN when the patient has documented Gilbert syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 ULN when documented tumour liver involvement)\n8. Adequate renal function: estimated creatinine clearance ≥ 60 mL\u002Fmin according to the Cockcroft-Gault formula\n9. Adequate cardiac function: left ventricular ejection fraction ≥50% at baseline as determined by either echocardiogram or multigated acquisition scan (MUGA)\n10. Adequate biliary drainage, with no evidence of ongoing infection\n11. Men, and women of childbearing potential (WOCBP) must agree to use adequate contraception for the duration of trial participation and as required after completing study treatment. Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.\n12. Women of childbearing potential must have a negative serum pregnancy test performed within 3 days before the date of randomisation\n13. Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, and other study procedures\n14. Affiliated to a social security system or in possession of equivalent private health insurance (according to local country health provision arrangements)\n\nExclusion Criteria:\n\n1. Disease progression occurring at any time prior randomisation, or toxicity that led to the discontinuation of the 1L-SoC before 4 full cycles have been delivered\n2. Toxicities from 1L-SoC not resolved to Grade ≤ 1 (according to version 5.0 the National Cancer Institute - Common terminology criteria for adverse events \\[NCI-CTCAE v5.0\\]) before randomisation, with the exception of alopecia\n3. Contraindication or known hypersensitivity to the MTT for the molecular alteration found in the patient, or any component in their formulation Note: For patients with multiple target alterations, contraindication to one MTT will not warrant exclusion if MTT to an alternative target is feasible.\n4. Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers\n5. Major surgery within 4 weeks of randomisation\n6. Radiotherapy within 7 days of randomisation\n7. Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as subjects who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks at the time of screening).\n8. Clinically significant cardiovascular disease (recent acute myocardial infarction, treated congestive heart failure \\[2 or above on the New York Heart Association functional classification scale\\], recent thromboembolic or cerebrovascular events \\[within 12 weeks, excepted if related to indwelling catheter\\], known prolonged QT syndrome).\n9. Cardiorespiratory pathologies where hyperhydration is contraindicated.\n10. Manifestation of tinnitus and\u002For hearing loss since initiation of cisplatin therapy.\n11. Known leptomeningeal disease. If leptomeningeal disease has been reported radiographically on baseline magnetic responance imaging (MRI), but is not suspected clinically by the investigator, the subject must be free of neurological symptoms.\n12. Concurrent malignancy (other than ABC), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years or more and are deemed at negligible risk for recurrence, are eligible for the trial\n13. Concomitant treatment with phenytoin in prophylactic use where this cannot be substituted for another therapy\n14. Known active hepatitis B virus or hepatitis C virus infection or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome\n15. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol\n16. Women who are pregnant or breast-feeding\n17. Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable\n18. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons\n19. Individuals deprived of liberty or placed under protective custody or guardianship\n\nADDITIONAL EXCLUSION CRITERIA FOR SPECIFIC MTTs:\n\nPatients assigned to receive oral therapies:\n\n1. Inability or unwillingness to swallow pills\n2. History of malabsorption syndrome or other condition that would interfere with enteral absorption. For example, active intestine inflammation (e.g., Crohn's disease or ulcerative colitis) requiring immunosuppressive therapy\n\nFutibatinib:\n\n1. History and\u002For current evidence of any of the following disorders:\n\n   1. Non-tumour related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator\n   2. Ectopic mineralization\u002Fcalcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator\n   3. Retinal or corneal disorder confirmed by retinal\u002Fcorneal examination and considered clinically significant in the opinion of the Investigator\n2. Concomitant treatment with strong CYP3A\u002FP-gp inhibitors or strong or moderate CYP3A\u002FP gp inducers where these cannot be substituted for another therapy.\n\nIvosidenib:\n\n1. Patients with history of torsade de pointes\n2. Concomitant treatment with digoxin where this cannot be substituted for another therapy\n3. Patients with a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450 msec or other factors that increased the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT interval syndrome)\n4. Concomitant treatment with strong CYP3A4 inducers or dabigatran where these cannot be substituted for another therapy\n5. Concomitant treatment with medicinal products known to prolong the QTc interval, or moderate or strong CYP3A4 inhibitors where these cannot be substituted for another therapy\n6. Familial history of sudden death or polymorphic ventricular arrhythmia.\n7. Hypokalemia, hypomagnesemia or hypocalcemia where this cannot be corrected by supplementation\n\nZanidatamab:\n\n1. Treatment with anthracyclines within 90 days before first dose of zanidatamab and\u002For total lifetime load exceeding 360 mg\u002Fm2 Adriamycin® or equivalent\n2. Use of corticosteroids administered at doses equivalent to \\> 15 mg per day of prednisone within 2 weeks of first zanidatamab dosing unless otherwise approved by the coordinating investigator. Topical, ocular, intra-articular, intranasal, and\u002For inhalational corticosteroids are permitted\n3. QTcF \\> 470 ms\n4. History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure\n5. Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease\n6. Clinically significant infiltrative pulmonary disease not related to lung metastases\n7. A history of life-threatening hypersensitivity to monoclonal antibodies or recombinant proteins\n\nNeratinib \\& trastuzumab:\n\n1. Patients with severe hepatic impairment (Child-Pugh Class C)\n2. Co-administration with the following medical products that are strong inducers of the CYP3A4\u002FP-gp isoform of cytochrome P450, such as carbamazepine, phenytoin (antiepileptics), St John's wort (Hypericum perforatum) or rifampicin (antimycobacterial)\n3. Patients who are experiencing dyspnoea at rest due to complications of advanced malignancy or co-morbidities\n4. Hypersensitivity to murine proteins\n5. Current active pneumonitis within 90 days of receiving trastuzumab or a known history of interstitial lung disease\n\nEncorafenib \\& binimetinib:\n\n1. Patients with a history or current evidence of retinal vein occlusion or risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or history of hyperviscosity or hypercoagulability syndrome)\n2. Patients with concurrent neuromuscular disorders associated with elevated creatine phosphokinase (\\>ULN)\n3. Patients with hypokalemia, hypomagnesemia, or hypocalcemia (i.e. Serum potassium, magnesium or calcium \\\u003C lower normal limit)\n4. Patients with a QTcF ≥ 450 msec for men, or ≥ 470 msec for women\n5. Current or expected use of a strong inhibitor of CYP3A4",{"count":180,"type":21},800,[182],"PHASE3","The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment.\n\nThe trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.",[29],[29,186,187],"Targeted therapy","Personalised medicine","2026-05-18",{"date":163,"type":41},{"date":191,"type":41},"2024-07-18",{"date":193,"type":21},"2028-06",{"name":195,"class":71},"UNICANCER",69,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":58,"phases":207,"briefSummary":208,"conditions":209,"keywords":248,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100565188","phase-2-agnostic-therapy-in-rare-solid-tumors-100565188","NCT06638931","Agnostic Therapy in Rare Solid Tumors","Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 (Anti-PD1) Monoclonal Antibody in Patients With Advanced Rare Tumors","ANTARES","Inclusion Criteria\n\n1. Age 18 years or older.\n2. Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher.\n3. Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population.\n4. Documented disease progression radiologically after the last routine treatment.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment.\n7. Male participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. No fertile partner;\n   3. Has a fertile partner who agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n\n      and\n   4. Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab.\n8. Female participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n9. Estimated life expectancy greater than 12 weeks, as determined by the investigator or delegated sub-investigator.\n10. Preserved organ functions defined by:\n\n    * Absolute neutrophil count ≥ 1,000;\n    * Hemoglobin ≥ 8.0 g\u002FdL (patients may receive transfusions to reach this level);\n    * Platelet count ≥ 100,000;\n    * Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), or ≤ 3.0 × ULN for patients with Gilbert's syndrome;\n    * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases);\n    * Creatinine clearance \\> 30 mL\u002Fmin (estimated by Cockcroft-Gault).\n11. Diagnosis of rare cancer (List I) confirmed by histopathological examination, with the possibility of including other types of rare tumors (incidence of less than 6 in every 100,000) after careful evaluation and approval by the study board.\n\n    * List I:\n\n      * Urachal adenocarcinoma\n      * Parathyroid carcinoma\n      * Nasopharyngeal epithelial tumors\n      * Fibrolamellar carcinoma of any primary site\n      * Angiosarcoma of any primary site\n      * Secretory breast carcinoma\n      * Anal cancer\n      * Metaplastic breast carcinoma\n      * Chromophobe renal carcinoma, Microphthalmia-associated Transcription Factor (MiT) family translocation renal carcinoma; renal carcinoma with Fumarate Hydratase (FH) or Succinate Dehydrogenase (SDH) deficiency\n      * Carcinosarcoma of any primary site\n      * Small intestine cancer\n      * Cholangiocarcinoma\n      * Sertoli-Leydig cell tumors\n      * Cervical cancer of non-epidermoid histology\n      * Tracheal epithelial tumors\n      * Non-cystadenoma salivary gland tumors\n      * Mesothelioma of any site\n      * Neuroblastoma\n      * Adrenal cancer\n      * Penile cancer\n      * Apocrine carcinoma\n      * Fibrosarcoma of any primary site\n      * Cancer of unknown primary site\n      * Hemangioblastoma of any primary site\n      * Thyroid cancer\n      * Hepatoblastoma\n      * Fallopian tube cancer\n      * Leiomyosarcoma of any primary site\n      * Vaginal cancer\n      * Neurofibrosarcoma of any primary site\n      * Gallbladder cancer\n      * Osteosarcoma of any primary site\n      * Bile duct cancer\n      * Clear cell endometrial carcinoma\n      * Yolk sac tumor of any primary site\n      * Non-epidermoid bladder cancer\n      * Vulvar cancer\n      * Kaposi's sarcoma\n      * Epithelial ovarian cancer\n      * Soft tissue sarcoma\n      * Urethral cancer\n      * Granulosa cell tumor of any primary site\n      * Cystadenoma carcinoma\n      * Primitive neuroectodermal tumor of any primary site\n      * Pure or mixed neuroendocrine tumors with neuroendocrine component\n      * Trophoblastic tumor\n\nExclusion Criteria\n\n1. Previous treatment lines with immunotherapy (immune checkpoint inhibitors).\n2. Pregnant or breastfeeding individuals.\n3. Limiting comorbidity, in the opinion of the investigator.\n4. Active infection.\n5. Major surgery within the last 4 weeks.\n6. Functional class II or greater heart failure.\n7. Myocardial infarction or stroke within the last 6 months.\n8. History of pulmonary fibrosis or pneumonitis.\n9. Autoimmune diseases, except for patients with vitiligo and\u002For controlled thyroid\u002Fhypothyroidism without the use of immunosuppressors.\n10. Second invasive primary tumor diagnosed in the last 3 years and\u002For with active disease, except for localized skin tumors (non-melanoma) that have been treated with curative intent.\n11. Patients with prolonged QT interval.\n12. Uncontrolled Central Nervous System (CNS) metastases. Patients who have previously received local treatment, such as radiotherapy, will be eligible if clinical and radiological stability is demonstrated in the 2 weeks prior to the start of treatment. Patients must not be using corticosteroids for managing CNS disease.\n13. Presence of meningeal carcinomatosis.\n14. Worsening renal and liver function in the 14 days prior to enrollment.\n15. History of solid organ transplantation with or without immunosuppression.\n16. Patients with untreated acquired immunodeficiency. Immunocompromised patients may be included as long as they do not have active opportunistic disease and\u002For active infection, after thorough clinical evaluation by the investigator or sub-investigator. HIV-positive patients must have documented undetectable viral load prior to inclusion.\n17. Chronic use of corticosteroids at doses greater than 10 mg\u002Fday of prednisone or equivalent. Patients with adrenal insufficiency of non-autoimmune etiology (e.g., previous bilateral adrenalectomy) may be included if they are clinically compensated with 10 mg\u002Fday of prednisone or equivalent or less.",{"count":206,"type":21},28,[60],"The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.\n\nThe study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor's tissue type or location. Patients who have not responded to standard treatments will be included, and treatment will last for up to 12 months. The study will assess objective response, progression-free survival, and biomarkers such as PD-L1, ctDNA, and microvesicles, in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population",[210,211,212,213,214,215,216,217,218,219,134,220,221,28,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,29,237,238,239,240,241,242,243,244,245,246,247],"Urachal Cancer","Parathyroid Carcinoma","Fibrolamellar Carcinoma","Angiosarcoma","Secretory Carcinoma of Breast","Anal Neoplasms","Metaplastic Breast Carcinoma","Translocation Renal Cell Carcinoma","Carcinosarcoma","Small Intestine Neoplasms","Sertoli-Leydig Cell Tumor","Adenoid Cystic Carcinoma","Neuroblastoma","Adrenal Gland Neoplasms","Penile Neoplasms","Apocrine Carcinoma","Fibrosarcoma","Cancer of Unknown Primary","Hemangioblastoma","Thyroid Neoplasms","Hepatoblastoma","Fallopian Tube Neoplasms","Leiomyosarcoma","Vaginal Neoplasms","Neurofibrosarcoma","Gallbladder Neoplasms","Osteosarcoma","Clear Cell Endometrial Cancer","Yolk Sac Tumor","Vulvar Neoplasms","Kaposi Sarcoma","Ovarian Epithelial Cancer","Soft Tissue Sarcoma","Urethral Neoplasms","Granulosa Cell Tumor","Primitive Neuroectodermal Tumor","Neuroendocrine Tumors","Trophoblastic Tumor",[249,211,250,212,213,251,252,216,253,218,254,134,255,256,257,258,28,222,259,260,225,226,227,228,261,230,262,232,263,234,127,236,264,237,238,265,266,240,241,242,267,244,221,245,246,247],"Urachal Adenocarcinoma","Nasopharyngeal Epithelial Tumors","Secretory Breast Carcinoma","Anal Cancer","Chromophobe Renal Carcinoma","Small Intestine Cancer","Sertoli-Leydig Cell Tumors","Non-Squamous Cervical Neoplasm","Tracheal Epithelial Tumors","Non-Adenoid Cystic Salivary Tumors","Adrenal Neoplasm","Penile Cancer","Thyroid Cancer","Fallopian Tube Cancer","Vaginal Cancer","Biliary Tract Cancer","Non-Squamous Bladder Cancer","Vulvar Cancer","Urethral Cancer","2026-04-10",{"date":270,"type":41},"2026-04-15",{"date":272,"type":41},"2024-07-16",{"date":274,"type":21},"2028-05",{"name":276,"class":71},"Instituto do Cancer do Estado de São Paulo",8,{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":58,"phases":288,"briefSummary":289,"conditions":290,"keywords":294,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":4},"100633905","impact-of-intraoperative-ptcd-catheter-retention-versus-removal-on-postoperative-short-term-outcomes-after-pancreaticoduodenectomy-in-obstructive-jaundice-100633905","NCT07532759","Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice","Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice: An Exploratory Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 to 85 years\n* Patients with pancreatic head or periampullary tumors scheduled for pancreaticoduodenectomy\n* Presence of obstructive jaundice and completion of preoperative\n* percutaneous transhepatic cholangial drainage (PTCD)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* American Society of Anesthesiologists (ASA) physical status ≤ II\n* Able to understand the study and provide written informed consent\n\nExclusion Criteria:\n\n* Presence of distant metastasis or locally unresectable disease\n* Severe cardiac, renal, or pulmonary dysfunction that contraindicates surgery\n* Uncontrolled infection\n* Pregnancy or breastfeeding\n* History of major surgery within 4 weeks prior to enrollment\n* Poor compliance or inability to complete follow-up","85 Years",{"count":287,"type":21},100,[158],"Pancreaticoduodenectomy (PD) is a complex surgical procedure commonly performed for tumors of the pancreatic head and periampullary region. Many patients present with obstructive jaundice and undergo preoperative percutaneous transhepatic cholangial drainage (PTCD) to relieve biliary obstruction. However, there is currently no consensus on whether the PTCD catheter should be removed or retained during surgery.\n\nThis multicenter, prospective randomized controlled trial aims to compare two intraoperative strategies: removal versus retention of the PTCD catheter during PD. Participants will be randomly assigned to either group. The study will evaluate whether these different approaches influence postoperative outcomes, particularly major complications such as bile leak and severe postoperative morbidity within 90 days after surgery.\n\nIn addition to complications, the study will assess recovery after surgery, including return of gastrointestinal function, length of hospital stay, and quality of recovery, as well as laboratory indicators of liver function and inflammation.\n\nThe results of this study are expected to provide evidence to guide surgical decision-making regarding PTCD management during PD and to improve patient outcomes.",[291,292,293,29],"Obstructive Jaundice","Pancreatic Head Cancer","Periampullary Neoplasms",[295,296,297,298,299,300,301],"Pancreaticoduodenectomy","PTCD","Biliary drainage","Biliary complications","Bile leak","Enhanced recovery","Randomized controlled trial","2026-04-09",{"date":304,"type":41},"2026-04-16",{"date":306,"type":21},"2026-05-01",{"date":308,"type":21},"2028-04-30",{"name":310,"class":71},"Xu'an Wang",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":58,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":329,"locationsCount":4},"100432382","phase-2-multicenter-phase-2-study-of-envafolimab-in-biliary-tract-cancers-100432382","NCT04910386","Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers","A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers","Inclusion Criteria:\n\n1. Be ≥ 18 years of age;\n2. Subjects must have a histopathological or cytological diagnosis of locally advanced or metastatic gallbladder cancer (GBC) or cholangiocarcinoma (CCA);\n3. Subjects who have not received prior systemic therapy for advanced disease or who have received adjuvant or neoadjuvant chemotherapy in one regimen and relapsed \\> 6 months after the end of chemotherapy can be enrolled;\n4. Child-Pugh liver function rating: class A (5-6 points) and better class B (7 points) (see Appendix 3);\n5. ECOG PS score 0 or 1 (see Appendix 1);\n6. Expected survival ≥ 12 weeks;\n7. Subjects with at least one measurable lesion (RECIST 1.1 criteria, see Appendix 2);\n8. Subject must have adequate major organ and bone marrow functions (no blood transfusion and no use of hematopoietic growth factor within 14 days before the first dose of study treatment):\n\n1\\) Hematology: neutrophils ≥ 1.5 × 109\u002FL, platelets ≥ 100 × 109\u002FL, and hemoglobin ≥ 90 g\u002FL; 2) International normalized ratio (INR) ≤ 1.5 × upper limit of normal (ULN) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 3) Liver function: serum total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels \\>1.5 ULN; Aspartate aminotransferase (AST \\[SGOT\\]) and alanine aminotransferase (ALT \\[SGPT\\]) ≤ 2.5 × ULN OR ≤ 5 × ULN for subjects with liver metastases; 4) Renal function: serum creatinine ≤ 1.5 x ULN and creatinine clearance (CCr) \\> 60 mL\u002Fmin (assessed with Cockcroft-Gault formula, see Appendix 6); 5) Normal cardiac function with left ventricular ejection fraction (LVEF) ≥ 50% by two-dimensional echocardiography.\n\n9\\. Subjects must fully understand the study, voluntarily participate, and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Has participated in another clinical trials of other investigational drugs or investigational devices within 4 weeks prior to the first dose of investigational product treatment (palliative radiotherapy for bone metastases completed at least 2 weeks prior to investigational product treatment is allowed);\n2. The investigator assesses liver metastases as 50% or more of the total liver volume;\n3. Has ascites requiring drainage or treatment with diuretics, or pleural or pericardial effusion requiring drainage and\u002For associated with symptoms of tachypnea within 4 weeks prior to the first dose of investigational product treatment;\n4. Has biliary obstruction with clinical intervention that has not resolved or requires anti-infective therapy as judged by the investigator 14 days prior to the first dose of investigational product treatment;\n5. Has prior liver transplantation;\n6. Has known active brain metastases or spinal cord compression; subjects with previously treated brain metastases may be enrolled if their clinical condition is stable and radiographic evidence shows no disease progression within 4 weeks prior to the first dose of investigational product treatment, and corticosteroid therapy is not required within 4 weeks prior to the first dose of investigational product treatment;\n7. Has a known additional malignant tumor in the past 5 years (except for skin basal cell or squamous cell carcinoma, or cervical, breast and other carcinoma in situ after radical surgery);\n8. Has received major surgical procedures (except biopsy) or incomplete healing of surgical wound within 4 weeks prior to the first dose of investigational product treatment;\n9. Has any unresolved toxicity (CTCAE Grade ≥ 2) from prior anti-tumor therapy, except for alopecia or Grade 2 peripheral neuropathy or other laboratory abnormalities that are not clinically significant as assessed by the investigator;\n10. Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma\u002Fatopy would be exception to this rule. Subjects who require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism that is stable on hormone replacement will not be excluded from the study;\n11. Has known history of HIV, or active bacterial or fungal infection requiring systemic treatment within 14 days prior to the first dose of investigational product treatment;\n12. Has history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic interstitial lung disease or presence of active pneumonitis on chest CT scan within 4 weeks before the first dose of investigational product treatment;\n13. Has active hepatitis B (HBsAg positive and HBV-DNA ≥ 104 copies\u002FmL) or hepatitis C (HCV antibody positive and HCV-RNA quantitative test results greater than the lower limit of detection);\n14. Has a history or current evidence of clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe\u002Funstable angina, acute ischemic\u002Fhemorrhagic stroke, congestive heart failure (≥ New York Heart Association Class II, see Appendix 4) within 6 months prior to enrollment; arrhythmias requiring treatment with other antiarrhythmic drugs in addition to β-blockers or digoxin; repeat QTcF interval \\> 450 milliseconds (ms) on ECG (see Appendix 5); hypertension not well controlled with antihypertensive drug therapy (systolic blood pressure \\> 150 mmHg, diastolic blood pressure \\> 100 mmHg);\n15. Be receiving therapeutic doses of warfarin (low-dose warfarin ≤ 2 mg\u002Fday is allowed); or receiving antiplatelet anticoagulant therapy (aspirin doses ≤ 300 mg\u002Fday and clopidogrel doses ≤ 75 mg\u002Fday are allowed);\n16. Has received immunosuppressive drugs within 4 weeks prior to the first dose of investigational product treatment, excluding topical corticosteroids or systemic prednisone ≤ 10 mg\u002Fday or equivalent doses of other corticosteroids;\n17. Has received live vaccines within 4 weeks before the first dose of investigational product treatment or plan to receive it during the study;\n18. Has history of severe allergic reactions to chimeric or human antibodies or fusion proteins, or known allergies to biological products produced with Chinese hamster ovary cells or any component of envafolimab; known or suspected allergy to the chemotherapeutic drug gemcitabine\u002Fcisplatin and its components;\n19. Be pregnant or breastfeeding;\n20. Be childbearing potential but unwilling to accept effective contraceptive measures;\n21. Any other disease, metabolic disorder or laboratory abnormalities, that the investigator considers that the subject is not suitable for the investigational product treatment, or will affect the interpretation of the study results, or put the subject at high risk.",{"count":319,"type":21},126,[60],"This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers",[29],"2026-03-23",{"date":325,"type":41},"2026-03-25",{"date":327,"type":21},"2027-06-01",{"date":145,"type":21},{"name":330,"class":331},"3D Medicines (Sichuan) Co., Ltd.","INDUSTRY",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":16,"minAge":339,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":58,"phases":342,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":359},"100604217","phase-2-trifluridinetipiracil--oxaliplatin-in-participants-with-advanced-or-metastatic-biliary-tract-cancer-100604217","NCT07146646","Trifluridine\u002FTipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer","A Phase II Trial of Trifluridine\u002FTipiracil Plus Oxaliplatin in Patients With Advanced or Metastatic Biliary Tract Cancer Following First-Line Therapy","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed biliary tract cancer (BTC) including cholangiocarcinoma and gallbladder carcinoma. Individuals with ampullary cancers will not be considered eligible. Cancer must be advanced stage or metastatic.\n* Participants must have received only one line of systemic therapy for advanced or metastatic BTCs.\n* Note: Individuals who have either progressed or are intolerant to the prior therapy can be included in this study.\n* Age \\>18 years on day of signing informed consent. Because no dosing or adverse event data are currently available on the use of FTD\u002FTPI in individuals ≤18 years of age, children are excluded from this study.\n* Performance status: ECOG performance status of 0 or 1.\n* At least one index lesion is measurable based on RECIST 1.1.\n* Participants must have organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelet count ≥75,000\u002FmcL\n  * AST (SGOT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases\n  * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases\n  * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with bilirubin levels \\>1.5 x ULN\n  * Serum Creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin for participants with creatinine levels \\>1.5 x ULN (Cockcroft-Gault method)\n* Participants must have recovered adequately from any major surgery, prior to starting therapy.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Agree to use adequate method of contraception.\n\nExclusion Criteria:\n\n* Participants receiving any other investigational agents.\n* Participant has received investigational therapy within 4 weeks or within 5 half-lives of the therapeutic agent (whichever is shorter).\n* Received more than one line of systemic therapy for bile duct cancer. Adjuvant therapy will not be counted as line of systemic therapy.\n* Receiving systemic steroid therapy (\\>10mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Prior treatment with FTD\u002FTPI or oxaliplatin.\n* Known additional malignancy that currently requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has already undergone potentially curative therapy.\n* Known central nervous system metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable without evidence of new or enlarging brain metastases and are not using steroids for at least 7 days prior to trial treatment.\n* Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (\\> 10 mg\u002Fday or equivalent of prednisone) or immunosuppressive agents. (thyroid disease and diabetes are allowed)\n* Interstitial lung disease or active, non-infectious pneumonitis.\n* Active infection requiring systemic antibiotics.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the individual's participation for the full duration of the trial, or is not in the best interest of the individual to participate, in the opinion of the treating investigator.\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating investigator.\n* Participants with uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations\u002Fsubstance abuse disorders that would limit compliance with study requirements.\n* Participants pregnant or breastfeeding expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months after the last dose of trial treatment. Pregnant or breastfeeding women are excluded from this study because it is unknown if the combination of FTD\u002FTPI and oxaliplatin create the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug combination, breastfeeding should be discontinued if the mother is enrolled on this trial.","19 Years",{"count":341,"type":21},27,[60],"Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combination of chemotherapy drugs called FOLFOX which consists of fluorouracil and oxaliplatin. Studies have shown that other treatments may work better to treat advanced BTC. In this study, investigators want to see if treating patients with the drug combination of trifluridine\u002Ftipiracil (FTD\u002FTPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD\u002FTPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).",[264,29,134,127,345],"Gallbladder Carcinoma",[347,348,349],"Trifluridine\u002Ftipiracil","FTD\u002FTPI","Oxaliplatin","2026-02-17",{"date":352,"type":41},"2026-02-19",{"date":354,"type":41},"2025-12-01",{"date":356,"type":21},"2027-04",{"name":358,"class":71},"Case Comprehensive Cancer Center",2,{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":16,"minAge":339,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":58,"phases":368,"briefSummary":369,"conditions":370,"keywords":373,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":47},"100613635","phase-1-a-phase-iib-randomized-clinical-trial-of-immune-checkpoint-inhibitor-based-maintenance-therapy-in-patients-with-advanced-biliary-tract-cancer-100613635","NCT07269158","A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n-Patients with advanced biliary tract cancer who have completed at least 8 cycles of Durvalumab plus Gemcitabine and Cisplatin treatment without radiologic evidence of disease progression, and are planned to receive Durvalumab maintenance therapy.\n\n(Patients treated with Pembrolizumab plus Gemcitabine\u002FCisplatin are also eligible if they are to continue Pembrolizumab monotherapy without Gemcitabine as maintenance therapy.)\n\n* Patients who are 20 years of age or older at the time of signing the informed consent form.\n* Patients with histologically confirmed biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma.\n\n(Patients with neuroendocrine tumors or sarcomas are excluded.)\n\n* Patients who are willing and able to provide written informed consent for participation in the study.\n* Patients with measurable disease according to RECIST version 1.1.\n* ECOG performance status of 0 or 1.\n* Estimated life expectancy ≥ 3 months.\n* Patients with adequate organ and bone marrow function, without transfusion or administration of hematopoietic growth factors (e.g., G-CSF) within 2 weeks prior to treatment initiation, defined as follows:\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n* Platelet count ≥ 75 × 10⁹\u002FL\n* Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or estimated creatinine clearance ≥ 45 mL\u002Fmin (calculated using the Cockcroft-Gault formula; see Appendix 7)\n* AST and ALT ≤ 3.0 × ULN (≤ 5.0 × ULN if liver metastases are present)\n* Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome)\n* International normalized ratio (INR) ≤ 1.5 or prothrombin time ≤ 1.5 × ULN\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n* Women of childbearing potential must agree to use highly effective contraception during the entire study period and for at least 6 months after the last dose of investigational product, and must have a negative serum pregnancy test within 14 days prior to first dose.\n* Male patients who have not undergone sterilization must agree to use highly effective contraception during the entire study period and for at least 120 days after the last dose of investigational product.\n* Patients who are willing to provide tumor tissue samples obtained by endoscopic biopsy or excisional biopsy.\n* Patients who are able to understand and comply with the study procedures and are considered likely to complete the study by the investigator.\n\nExclusion Criteria:\n\n1. Patients who have received more than 10 cycles of immune checkpoint inhibitor (ICI) plus Gemcitabine and Cisplatin combination therapy for advanced biliary tract cancer.\n2. Patients who have been treated for, or have evidence of recurrence or progression of, any malignancy other than biliary tract cancer within the past 3 years.\n\n   Exceptions: Patients who have been disease-free for ≥3 years after curative treatment, or patients with the following malignancies are not excluded: basal cell carcinoma of the skin, Stage I squamous cell carcinoma of the skin, carcinoma in situ, intramucosal carcinoma, or superficial bladder carcinoma.\n3. Patients with residual adverse events from prior therapy or surgery that may interfere with the safety evaluation of the investigational product.\n4. Patients with a history of hypersensitivity to any component of monoclonal antibody products.\n5. Patients with a history or evidence of active, non-infectious interstitial lung disease (pneumonitis).\n6. Patients with symptomatic or clinically active brain or leptomeningeal metastases requiring treatment.\n\n   (Patients with asymptomatic, stable, and untreated brain metastases may be enrolled.)\n7. Patients who are immunodeficient or are receiving systemic corticosteroids or other immunosuppressive therapy within 7 days prior to the first dose of the investigational product.\n\n   (Physiologic doses of corticosteroids, such as for acute asthma exacerbation, may be allowed after consultation with the principal investigator.)\n8. Patients with uncontrolled or significant cardiovascular disease, defined as any of the following:\n\n   * Myocardial infarction within 180 days prior to randomization\n   * Uncontrolled angina within 180 days prior to randomization\n   * Congestive heart failure classified as New York Heart Association (NYHA) Class III or IV\n   * Uncontrolled hypertension despite appropriate therapy (systolic ≥150 mmHg or diastolic ≥90 mmHg for \\>24 hours)\n   * Clinically significant arrhythmia requiring treatment\n9. Patients with severe chronic infections or active infections, including active or previously known tuberculosis.\n10. Patients with active autoimmune disease that has required systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years.\n\n    (Replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, is not considered systemic treatment.)\n11. Patients who have received any anticancer therapy other than immune checkpoint inhibitor + Gemcitabine + Cisplatin combination therapy for biliary tract cancer.\n\n    (Adjuvant chemotherapy completed ≥6 months before study drug initiation is permitted.)\n12. Patients who have undergone major surgery under general anesthesia within 28 days or minor\u002Flocal surgery within 14 days before the start of study treatment.\n\n    (Diagnostic procedures such as laparoscopic biopsy may be allowed upon investigator's discretion.)\n13. Patients who, in the opinion of the investigator, have any condition, treatment, active or ongoing symptomatic infection, or abnormal laboratory finding that could confound study results, interfere with study participation, or pose undue risk to the patient.\n14. Patients with a known history of psychiatric disorders or substance abuse that may interfere with compliance to study requirements.\n15. Patients with a known history of human immunodeficiency virus (HIV-1\u002F2) infection.\n16. Patients with active hepatitis B (HBsAg-positive and HBV DNA detected) or active hepatitis C (anti-HCV positive with detectable HCV RNA).\n\n    Exception: Patients with inactive or asymptomatic HBV carriers, chronic HBV infection, or non-active HCV infection are eligible if HBV DNA \\\u003C 500 IU\u002FmL (or \\\u003C 2500 copies\u002FmL) at screening.\n17. Pregnant or breastfeeding women.\n18. Patients who have received any unapproved or investigational drug, combination product, or formulation within 28 days prior to the start of study treatment.\n19. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this clinical study.",{"count":367,"type":21},160,[121,60],"\"Biliary tract cancer (BTC) is a rare malignancy with a poor prognosis. Most patients present with unresectable disease, and even after curative-intent resection, recurrence is common. Since the ABC-02 trial, gemcitabine plus cisplatin (Gem\u002FCis) has been established as the standard first-line regimen, but the median overall survival (OS) remains approximately 11.7 months. Recent studies combining immune checkpoint inhibitors (ICIs) such as durvalumab or pembrolizumab with Gem\u002FCis have improved OS to 12.7-12.9 months, establishing ICI-based combination therapy as the new standard. However, the optimal maintenance therapy following initial chemoimmunotherapy remains undefined.\n\nThis phase IIb study enrolls patients with advanced BTC who achieved disease control after at least eight cycles of Gem\u002FCis plus ICI. The trial compares the efficacy and safety of ICI monotherapy maintenance versus ICI in combination with lenvatinib, venadaparib, or interleukin-2 (IL-2, SLC-3010).\n\nLenvatinib, through inhibition of FGFR2 and modulation of the tumor immune microenvironment, is expected to enhance ICI efficacy. PARP inhibitors may be beneficial in patients with homologous recombination deficiency (HRD) or platinum-sensitive disease. Additionally, IL-2 can activate tumor-infiltrating lymphocytes and alleviate the immunosuppressive microenvironment, potentially augmenting ICI responsiveness.\n\nThis study aims to explore a novel maintenance strategy integrating molecular targeted therapy, DNA damage repair modulation, and cytokine-based immunotherapy to overcome the limitations of current ICI monotherapy in BTC. The combination approach is expected to improve disease control and survival outcomes in patients with advanced BTC.",[29,371,372],"Advanced Cancer","Immunotherapy",[374],"Biliary Tract Neoplasms [including Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, and Gallbladder Neoplasms]","2025-12-05",{"date":377,"type":41},"2025-12-08",{"date":379,"type":21},"2025-12",{"date":381,"type":21},"2029-09",{"name":383,"class":71},"Yonsei University",{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":58,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":4},"100605266","phase-2-the-efficacy-and-safety-of-trilaciclib-in-bone-marrow-protection-before-chemotherapy-for-advanced-bile-duct-cancer-and-pancreatic-cancer-100605266","NCT07160283","The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer","Inclusion Criteria:\n\n1. Age \\>18 years, male or female.\n2. Pathologically confirmed diagnosis of cholangiocarcinoma or pancreatic cancer requiring chemotherapy-based treatment.\n3. ECOG performance status ≥0 (or 1), anticipated survival ≥3 months, and ability to complete ≥3 months of follow-up.\n4. No clinically significant abnormalities in complete blood count, hepatic\u002Frenal function, cardiac enzymes, or electrocardiogram (ECG).\n5. Voluntary participation with good compliance and willingness to undergo safety and survival follow-up.\n6. Signed written informed consent form prior to enrollment.\n\nExclusion Criteria:\n\n1. History of myeloid leukemia, myelodysplastic syndrome, or concurrent sickle cell disease.\n2. Symptomatic CNS metastases and\u002For leptomeningeal disease requiring immediate radiotherapy or steroid therapy.\n3. Major surgery or radiotherapy within 4 weeks prior to the first dose of study drug.\n4. History of interstitial lung disease, slowly progressive dyspnea with dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, multiple allergies, or peripheral arterial disease.\n5. Concurrent requirement for radiotherapy.\n6. Known hypersensitivity to any component of the study drug formulation.\n7. Pregnancy or lactation.\n8. Any other condition deemed by the investigator to compromise patient safety or study validity.",{"count":391,"type":21},96,[60],"Evaluate the efficacy and safety of Trilaciclib for myeloprotection prior to chemotherapy in advanced cholangiocarcinoma or pancreatic cancer.",[29,27],"2025-08-29",{"date":397,"type":41},"2025-09-08",{"date":399,"type":21},"2025-09-01",{"date":401,"type":21},"2028-09-01",{"name":403,"class":71},"The Second Affiliated Hospital of Shandong First Medical University",{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":410,"targetDuration":4,"studyType":58,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":4},"100601336","phase-2-the-safety-and-efficacy-of-benmelstobart-injection-in-patients-with-advanced-biliary-tract-malignant-tumors-100601336","NCT07109167","The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors","Inclusion Criteria\n\nAge: 18 to 75 years old, inclusive; of either sex. Histopathologically confirmed unresectable and previously untreated gallbladder cancer or intrahepatic\u002Fextrahepatic cholangiocarcinoma, with at least one measurable lesion per RECIST v1.1 criteria. Tissue samples must be provided for biomarker analysis, preferably recently obtained tissue. If recent tissue is unavailable, 5-8 archived 5μm-thick paraffin-embedded sections are acceptable.\n\nECOG performance status: 0 or 1. Life expectancy ≥12 weeks.\n\nNormal major organ function, defined as meeting the following criteria:\n\n1. Hematological tests:\n\n   1. Hemoglobin (HB) ≥90 g\u002FL (without blood transfusion within 14 days prior).\n   2. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL.\n   3. Platelet count (PLT) ≥80×10⁹\u002FL.\n2. Biochemical tests:\n\n   1. Albumin (ALB) ≥30 g\u002FL (without albumin transfusion within 14 days prior).\n   2. ALT and AST \\\u003C2.5×upper limit of normal (ULN); if liver metastases are present, ALT and AST ≤5×ULN.\n   3. Total bilirubin (TBIL) ≤1.5×ULN.\n   4. Plasma creatinine ≤1.5×ULN; or creatinine clearance (CCr) ≥60 ml\u002Fmin. Subject voluntarily agrees to participate, signs the informed consent form, and is able to comply with scheduled study visits and procedures.\n\nFemale subjects of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after treatment completion.\n\nExclusion Criteria Confirmed allergy to any component of Benmelstobart Injection. Uncontrolled hypertension (systolic blood pressure \\>140 mmHg and diastolic blood pressure \\>90 mmHg), coronary heart disease of Grade I or higher, arrhythmia of Grade I or higher (including QTc interval prolongation: males \\>450 ms, females \\>470 ms), or heart failure of Grade I or higher; patients with positive urine protein.\n\nPatients with definite gastrointestinal bleeding tendency, including: active local ulcerative lesions with fecal occult blood test (++); history of melena or hematemesis within 2 months.\n\nCoagulopathy (INR \\>1.5, APTT \\>1.5×ULN) or bleeding tendency. Multiple factors affecting oral drug absorption (e.g., inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).\n\nPatients with central nervous system metastases. Pregnant or lactating women. Patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).\n\nPatients with a history of psychotropic drug abuse who are unable to abstain or with mental disorders.\n\nPatients who participated in other drug clinical trials within 4 weeks. Patients with abnormal thyroid function. Urine protein ≥++ or 24-hour urine protein \\>1.0 g. Radiotherapy to target lesions within 4 weeks prior to the first dose of study treatment.\n\nUse of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding nasal, inhaled, or other topical glucocorticoids or physiological doses of systemic glucocorticoids (i.e., ≤10 mg\u002Fday prednisone or equivalent dose of other glucocorticoids).\n\nAdministration of live attenuated vaccines within 4 weeks prior to the first dose of study treatment or planned during the study period.\n\nMajor surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or unhealed wounds, ulcers, or fractures.\n\nActive, known, or suspected autoimmune disease or history of such diseases within the past 2 years (patients with vitiligo, psoriasis, alopecia, or Graves' disease that did not require systemic treatment in the past 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type 1 diabetes requiring only insulin replacement therapy are eligible).\n\nUncontrolled concurrent diseases including but not limited to: HIV infection (HIV antibody positive); active or poorly controlled severe infections.\n\nSymptomatic congestive heart failure (New York Heart Association class II-IV) or symptomatic or poorly controlled arrhythmias.\n\nHistory of interstitial lung disease. Pregnant or lactating female patients. Known history of primary immunodeficiency. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.",{"count":57,"type":21},[60],"Evaluate the progression-free survival (PFS) of benmelstobart combined with gemcitabine and cisplatin in first-line patients with advanced cholangiocarcinoma, and the progression-free survival (PFS) of benmelstobart combined with anlotinib in second-line patients with advanced cholangiocarcinoma.",[29],"2025-07-31",{"date":416,"type":41},"2025-08-07",{"date":418,"type":21},"2025-08-01",{"date":420,"type":21},"2027-08-01",{"name":403,"class":71},{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":58,"phases":430,"briefSummary":431,"conditions":432,"keywords":435,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":47},"100544981","eus-guided-cds-vs-ercp-as-first-line-in-malignant-distal-obstruction-in-borderline-disease-carpediem-2-trial-100544981","NCT06375954","EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)","Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction in Borderline Disease: An Open-label, Multicenter Randomized Trial (CARPEDIEM-2 Trial)","Inclusion Criteria:\n\n* Malignant distal biliary obstruction diagnosed in patient considered BORDERLINE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter.\n* Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory)\n* Patient capable of understanding and\u002For singning the informed consent.\n* Patient who understands the type of study and will comply with all follow-up tests throughout its duration\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Severe coagulation disorder: INR \\> 1.5 non correctable with plasma administration and\u002For platelet count \\\u003C 50.000\u002Fmm3.\n* Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative\n* Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum.\n* Patients with prior biliary stents or other biliary drainages (e.g., PTCD).\n* Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y).\n* Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla.\n* Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture).\n* Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available.\n* Patients incapable of maintaining follow-up appointments (lack of adherence).\n* Lack of informed consent.",{"count":391,"type":21},[158],"The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.",[433,434,29],"Malignant Biliary Obstruction","Pancreatic Cancer",[436,437,438,439,440,441],"Choledochoduodenostomy","Therapeutic endoscopy","Biliary Drainage","Lumen apposing metal stent","ERCP","Biliopancreatic malignancy","2024-04-18",{"date":444,"type":41},"2024-04-19",{"date":446,"type":21},"2024-05-01",{"date":448,"type":21},"2027-05-01",{"name":450,"class":71},"Hospital Universitari de Bellvitge",{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":459,"targetDuration":4,"studyType":58,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":4},"100518985","phase-2-chemotherapy-combined-with-adebrelimab-and-mecapegfilgrastim-in-neoadjuvant-treatment-of-potentially-resectable-btc-100518985","NCT06037655","Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC","Gemcitabine\u002FCisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study","Modified","Inclusion Criteria:\n\n* Male or female\n* Age ≥ 18 years，≤ 75 years\n* Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically\n* Ability to provide written informed consent prior to participation in any study-related procedure\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1).\n* Adequate organ function\n\nExclusion Criteria:\n\n* Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma\n* Known history of a serious allergy to any monoclonal antibody\n* Any active malignancy prior to the start of treatment\n* Active or history of autoimmune disease\n* Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation\n* Pregnant or lactating women",{"count":57,"type":21},[60],"The purpose of this study is to assess the safety and efficacy of Gemcitabine\u002Fcisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.",[29],"2023-09-07",{"date":465,"type":41},"2023-09-14",{"date":467,"type":21},"2023-09-25",{"date":469,"type":21},"2026-12-31",{"name":70,"class":71},{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":478,"enrollmentInfo":479,"targetDuration":17,"studyType":22,"phases":4,"briefSummary":481,"conditions":482,"keywords":487,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":4},"100508172","the-construction-of-clinical-database-and-multiomics-biobank-based-on-a-multicentral-prospective-cohort-of-benign-and-malignant-biliary-tract-diseases-100508172","NCT05896956","The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective Cohort of Benign and Malignant Biliary Tract Diseases","The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective Cohort of Benign and Malignant Biliary Tract Diseases 胆道系统良恶性肿瘤前瞻性登记队列数据库与多组学生物样本库建设","Inclusion Criteria:\n\n1. Sign informed consent, have good compliance, and be willing to accept follow-up and provide blood samples.\n2. Age 18-74 years old, gender is not limited.\n3. Clinical diagnosis of benign and malignant tumors of the biliary system, including unoperated patients preliminarily diagnosed as benign and malignant tumors of the biliary tract according to the results of imaging examinations and laboratory tests, or pathological examination of patients treated with surgery confirmed as benign and malignant tumors of the gallbladder.\n4. The primary tumor is located in the extrahepatic bile duct, intrahepatic bile duct, gallbladder floor, gallbladder body, gallbladder neck or gallbladder duct.\n5. Karnofsky performance score greater than 50.\n\nExclusion Criteria:\n\n1. Patients with biliary malignant tumors, biliary malignant tumor foci are not primary lesions.\n2. Patients with biliary malignant tumors, combined with serious central nervous system diseases, respiratory diseases, autoimmune diseases, chronic renal insufficiency and other diseases, long-term use of immunosuppressants, combined with serious uncontrolled infections.\n3. Patients with biliary malignant tumors, who also have active cardiovascular and cerebrovascular diseases, have cerebrovascular accidents, myocardial infarction, unstable angina pectoris, or grade II. or above congestive heart failure according to the standards of the New York Heart Association, and require serious arrhythmias requiring drug treatment.\n4. Patients with biliary malignant tumors, women of childbearing age who have a positive blood pregnancy test or have not had a pregnancy test, pregnant or breastfeeding women.\n5. The patient is participating in other therapeutic clinical trials where treatment measures cannot be clarified or treatment information cannot be collected.","74 Years",{"count":480,"type":21},500,"The aim of the study is to establishing a standardized biobank and a clinical information database for patients with benign and malignant tumors of the biliary system. With follow-up plans and advanced multiomics technology, a multiomics database for patients with benign and malignant tumors of the biliary tract will be further established. Based on the above work, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy based on multiomics characteristics and molecular typing of biliary tract tumors.",[483,127,484,485,29,486],"Biliary Tract Diseases","Extrahepatic Bile Duct Cancer","Intrahepatic Cholangiocarcinoma","Gall Stone",[488,489,490,491,492],"biliary tract diseases","gallbladder cancer","biliary tract neoplasms","biliary tract cancer","cohort study","2023-06-01",{"date":495,"type":41},"2023-06-09",{"date":497,"type":21},"2023-07-01",{"date":499,"type":21},"2027-06-30",{"name":501,"class":71},"RenJi Hospital"]