[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-biliary-tract-cancerbtc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-biliary-tract-cancerbtc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100645464","phase-2-sacituzumab-tirumotecan-in-previously-treated-trop2-positive-advanced-biliary-tract-cancer-100645464",false,"NCT07701122","Sacituzumab Tirumotecan in Previously Treated TROP2-Positive Advanced Biliary Tract Cancer","A Single-Arm, Phase II, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan as Second-Line or Later Therapy in Patients With TROP2-Positive Advanced Biliary Tract Cancer","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for enrollment:\n\n1. Age ≥18 years, male or female.\n2. Histologically or cytologically confirmed locally advanced, recurrent, or metastatic biliary tract cancer, with disease progression after, or intolerance to, at least one prior line of systemic therapy.\n3. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n5. TROP2 expression by immunohistochemistry (IHC) ≥1+.\n6. Life expectancy of at least 3 months.\n7. Adequate organ and bone marrow function, without transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks before the first dose of study treatment, defined as follows:\n\n   1. Hematology: absolute neutrophil count ≥1.5 × 10\\^9\u002FL; platelet count ≥80 × 10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n   2. Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤2.5 × upper limit of normal (ULN); total bilirubin ≤1.5 × ULN; albumin ≥30 g\u002FL. For participants with liver metastases at baseline, ALT and AST must be ≤5 × ULN and total bilirubin must be ≤3 × ULN.\n   3. Renal function: serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL\u002Fmin as calculated using the standard Cockcroft-Gault formula.\n   4. Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤1.5 × ULN.\n8. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective medically accepted contraception from the time of signing the informed consent form until 6 months after the last dose of study treatment.\n9. Voluntarily agrees to participate in the study, provides written informed consent, has good compliance, and is willing to cooperate with study follow-up.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded:\n\n1. Prior treatment with any TROP2-directed therapy or any topoisomerase I inhibitor-containing therapy, including antibody-drug conjugate (ADC) therapy, whether administered in the adjuvant, neoadjuvant, or advanced disease setting.\n2. Ongoing or active infection.\n3. Participation in another clinical trial of an antitumor drug within 4 weeks before screening.\n4. History of another uncured malignancy within 5 years, except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n5. Known hypersensitivity to the study drug or any of its components.\n6. Any of the following cardiovascular or cerebrovascular diseases or risk factors:\n\n   1. Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, New York Heart Association (NYHA) class III or IV heart failure, symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other severe cardiovascular or cerebrovascular disease within 6 months before the first dose of study treatment.\n   2. History of myocarditis, primary cardiomyopathy, specific cardiomyopathy, or other myocardial disease.\n   3. Deep vein thrombosis within 3 months before the first dose of study treatment, unless stable for ≥2 weeks after treatment with low-molecular-weight heparin or a drug with similar efficacy; peripheral arterial thromboembolic event, pulmonary embolism, or other severe thromboembolic event within 3 months before the first dose of study treatment.\n   4. Life-threatening major vascular disease, such as aortic aneurysm or aortic dissecting aneurysm, or major vascular disease requiring surgery within 6 months before the first dose of study treatment.\n7. Uncontrolled systemic disease as judged by the investigator, including:\n\n   1. Poorly controlled diabetes mellitus, defined as fasting blood glucose ≥10 mmol\u002FL on two consecutive tests.\n   2. Poorly controlled hypertension, defined as systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg.\n   3. Symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once per week.\n8. History of noninfectious interstitial pulmonary fibrosis or noninfectious pneumonitis requiring steroid treatment; current interstitial pulmonary fibrosis or noninfectious pneumonitis; or suspected interstitial pulmonary fibrosis or noninfectious pneumonitis that cannot be ruled out by imaging during screening.\n9. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of severe corneal disease that may impair or delay corneal healing.\n10. Clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to severe asthma within 3 months before the first dose of study treatment, severe chronic obstructive pulmonary disease, restrictive lung disease, autoimmune, connective tissue, or inflammatory disease that may involve the lungs, such as rheumatoid arthritis, Sjögren syndrome, or sarcoidosis, or prior total pneumonectomy.\n11. Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding.\n12. Active gastrointestinal disease or other condition that may significantly affect the absorption, distribution, metabolism, or excretion of study treatment, such as refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow medication, or prior major bowel resection.\n13. Risk of esophagotracheal fistula or esophagopleural fistula, or tumor invasion or compression of surrounding vital organs or blood vessels, such as the heart, esophagus, or superior vena cava, accompanied by related symptoms, such as superior vena cava syndrome.\n14. Toxicities from prior antitumor therapy that have not recovered to Grade ≤1 according to NCI CTCAE version 5.0 or to the level specified in the eligibility criteria, except for toxicities considered by the investigator to pose low safety risk, such as alopecia or fatigue.\n15. Active autoimmune disease requiring systemic treatment within the past 2 years, including disease-modifying agents, immunosuppressive drugs, or systemic corticosteroids at a dose of \\>10 mg\u002Fday prednisone or equivalent. Hormone replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, is not considered systemic treatment. Participants who have received systemic corticosteroids at \\>10 mg\u002Fday prednisone or equivalent or other immunosuppressive drugs within 2 weeks before the first dose of study treatment will also be excluded.\n16. Severe infection within 4 weeks before the first dose of study treatment, including but not limited to infection with complications requiring hospitalization, sepsis, or severe pneumonia; or active infection requiring systemic anti-infective therapy within 2 weeks before the first dose of study treatment.\n17. Known active tuberculosis. Participants suspected of having active tuberculosis must undergo clinical evaluation to rule out active tuberculosis.\n18. Hepatitis B virus (HBV) infection with detectable HBV DNA, defined according to local laboratory requirements as ≥10 IU\u002FmL or above the lower limit of detection, unless antiviral therapy is initiated before treatment according to institutional practice to ensure adequate viral suppression and is maintained during the study and for 6 months after the last dose of study treatment. Participants who are anti-HBc positive but have undetectable HBV DNA do not require antiviral therapy unless HBV DNA becomes \\>10 IU\u002FmL or reaches the lower limit of detection according to local laboratory requirements during treatment.\n19. Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n20. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n21. Major surgery within 4 weeks before the first dose of study treatment, or anticipated need for major surgery during the study.\n22. Known hypersensitivity to the study drug or any of its components, including polysorbate 20, or history of severe hypersensitivity reaction to other biologic agents.\n23. Receipt of nonspecific immunomodulatory therapy within 2 weeks before the first dose of study treatment, including but not limited to interferon or interleukin-2, or Chinese patent medicines approved for antitumor indications.\n24. Receipt of strong cytochrome P450 3A4 (CYP3A4) inhibitors or strong CYP3A4 inducers within 7 days before the first dose of study treatment, or need to continue such medications during the study.\n25. Receipt of a live vaccine within 30 days before the first dose of study treatment, or planned receipt of a live vaccine during the study.\n26. Rapid disease deterioration during screening before study drug administration, such as a significant change in performance status.\n27. Pregnant or breastfeeding women.\n28. Any condition that, in the investigator's judgment, may interfere with evaluation of the study drug, compromise participant safety, affect interpretation of study results, or otherwise make the participant unsuitable for participation in this study.","ALL","18 Years",{"count":19,"type":20},33,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single-arm, Phase II, multicenter clinical trial evaluating sacituzumab tirumotecan in patients with TROP2-positive advanced biliary tract cancer who have experienced disease progression after, or intolerance to, at least one prior line of systemic therapy.\n\nEligible participants will receive sacituzumab tirumotecan monotherapy. The primary objective is to evaluate objective response rate as assessed by the investigator according to RECIST version 1.1. Secondary objectives include evaluation of progression-free survival, overall survival, and safety. Exploratory analyses will assess the association between TROP2 protein expression and clinical efficacy, as well as potential mechanisms of resistance.",[26],"Advanced Biliary Tract Cancer(BTC)",[28,29,30,31],"Biliary Tract Cancer","TROP2","Sacituzumab Tirumotecan","Antibody-Drug Conjugate","NOT_YET_RECRUITING","2026-07-12",{"date":35,"type":36},"2026-07-14","ACTUAL",{"date":38,"type":20},"2026-07-01",{"date":40,"type":20},"2028-07-01",{"name":42,"class":43},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100618016","a-prospective-observational-study-of-first-line-systemic-therapy-combined-with-celiac-plexus-blockade-for-advanced-biliopancreatic-cancer-with-pain-100618016","NCT07326137","A Prospective Observational Study of First-Line Systemic Therapy Combined With Celiac Plexus Blockade for Advanced Biliopancreatic Cancer With Pain","A Prospective Observational Study of First-Line Systemic Therapy Combined With Celiac Plexus Blockade in Patients With Advanced Biliopancreatic Malignancies and Cancer-Related Pain","Inclusion Criteria:\n\n* Histologically confirmed advanced biliopancreatic malignancy (including biliary tract cancer or pancreatic cancer).\n* Cancer-related pain: Baseline Numeric Rating Scale (NRS) pain score ≥ 4 points for over 1 week, with plans to receive celiac plexus neurolysis (CPN).\n* Scheduled to receive a first-line systemic treatment regimen (e.g., PD-1\u002FPD-L1 inhibitor monotherapy or in combination with chemotherapy\u002Ftargeted therapy).\n* ECOG Performance Status of 0-2 and an estimated life expectancy of ≥ 3 months.\n\nExclusion Criteria:\n\n* Previous history of celiac plexus neurolysis or ablation.\n* Coagulation disorders (INR \\> 1.5, platelet count \\\u003C 50 × 10⁹\u002FL).\n* Severe cardiac, hepatic, or renal insufficiency (Child-Pugh Class C, estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin, NYHA Class III-IV heart failure).\n* Contraindications to celiac plexus block (e.g., local infection, anatomical variation).\n* Any other condition that, in the investigator's judgment, would preclude safe participation in the study.",{"count":52,"type":20},103,"OBSERVATIONAL","This study is for patients with advanced bile duct or pancreatic cancer who are experiencing pain from their disease. The purpose of this research is to learn about the effects of combining a standard pain relief treatment (Celiac Plexus Block) with standard first-line cancer drugs.\n\nPatients in this study will receive the Celiac Plexus Block procedure, which is intended to reduce pain, and will then begin their standard cancer medication regimen. Researchers will observe and compare how well this combined approach works to control pain and the cancer itself, and will monitor for any side effects. Participation in this study involves being followed by the research team for up to 2 years to track health outcomes.\n\nThe goal is to see if starting cancer treatment together with this specialized pain management technique is more helpful for patients compared to what is already known about the standard treatments alone.",[26,56,57],"Advanced Pancreatic Cancers","Cancer-related Pain","RECRUITING","2026-02-10",{"date":61,"type":36},"2026-02-11",{"date":63,"type":36},"2025-12-26",{"date":65,"type":20},"2028-12-26",{"name":67,"class":43},"Tongji Hospital",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100619974","phase-2-a-phase-ii-trial-of-organoid-drug-sensitivity-testing-to-guide-therapy-in-unresectable-biliary-tract-cancers-100619974","NCT07351591","A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Biliary Tract Cancers","Patient-Derived Tumor Organoid Drug Sensitivity Testing to Guide Treatment Selection in Patients With Unresectable Biliary Tract Cancers: A Prospective, Non-randomized, Open-label, Single-Center Phase II Clinical Trial","Inclusion Criteria:\n\n1. Male or female, aged between 18 and 70 years (inclusive).\n2. Diagnosis of biliary tract malignancy confirmed according to the NCCN Clinical Practice Guidelines.\n3. The subject or their legal guardian understands and voluntarily signs the Informed Consent Form, and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures as required by the protocol.\n4. The subject is not a candidate for curative resection, transplantation, or local ablation therapy. This includes patients with recurrent disease after prior radical therapy who are not eligible for further curative resection or ablation.\n5. Life expectancy of at least 12 weeks.\n6. No radiotherapy within 12 weeks prior to the first dose of the study drug.\n7. Liver function classified as Child-Pugh Class A or Class B with a score of 7.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n9. Adequate organ and bone marrow function, defined by the following laboratory values within 7 days prior to randomization (without receiving any blood transfusions, hematopoietic growth factors, albumin, or other corrective drugs within 14 days prior to the laboratory tests):\n\n   9.1. Hematological:\n   * Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL\n   * Platelet count (PLT) ≥ 75 × 10⁹\u002FL\n   * Hemoglobin (HGB) ≥ 9.0 g\u002FdL 9.2. Hepatic:\n   * Total Bilirubin (TBIL) ≤ 3 × Upper Limit of Normal (ULN)\n   * Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP) ≤ 5 × ULN\n   * Serum Albumin ≥ 28 g\u002FL 9.3. Renal:\n   * Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CCr) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n   * Urinalysis indicates urine protein \\\u003C 2+; if baseline urinalysis shows urine protein ≥ 2+, a 24-hour urine collection must demonstrate 24-hour urine protein quantification \\\u003C 1 g.\n\n   9.4. Coagulation:\n\n   \\* International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN\n10. For women of childbearing potential (WOCBP), a negative urine or serum pregnancy test must be confirmed within 3 days prior to the first dose of study drug (Cycle 1, Day 1). If a urine test is inconclusive, a serum pregnancy test is required. WOCBP and male subjects must agree to use adequate contraception during the observation period and for at least 8 weeks after the last dose of the study drug. A woman is considered not of childbearing potential if she is postmenopausal (≥1 year without menses) or has undergone surgical sterilization (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation). Subjects (both male and female) with risk of pregnancy must use highly effective contraception (with a failure rate of \\\u003C1% per year) during the entire treatment period and for 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy agents).\n\nExclusion Criteria:\n\n1. Uncorrectable coagulopathy or individuals with a significant bleeding tendency.\n2. Evidence of any concurrent malignant disease.\n3. Diagnosis of another malignancy within 3 years prior to the first dose, except for radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and\u002For carcinoma in situ that has undergone curative resection.\n4. Patients requiring long-term anticoagulant or antiplatelet therapy that cannot be discontinued.\n5. Presence of hepatic encephalopathy or refractory pleural effusion\u002Fascites requiring therapeutic intervention.\n6. Other anti-tumor or systemic therapies within 2 weeks prior to enrollment:\n\n   * Treatment with Chinese herbal medicine with demonstrated anti-tumor properties.\n   * Treatment with Chinese herbal medicine with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin), except for localized use to control pleural effusion.\n7. History of systemic treatment for active autoimmune disease or ongoing immunosuppressive therapy:\n\n   * Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.\n   * Systemic corticosteroid therapy (excluding topical, intranasal, inhaled, or other local routes) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. The use of physiologic doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) is permitted.\n8. Severe hepatic or renal insufficiency.\n9. Presence of any severe or uncontrolled systemic disease, including but not limited to:\n\n   * Clinically significant, poorly controlled resting ECG abnormalities (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation).\n   * Unstable angina, congestive heart failure (New York Heart Association (NYHA) Class ≥ II).\n   * Myocardial infarction within 6 months prior to randomization.\n   * History of esophageal or gastric variceal bleeding within 6 months prior to enrollment.\n   * Poorly controlled hypertension (systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg).\n   * History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease.\n   * Active tuberculosis.\n   * Active or uncontrolled infection requiring systemic therapy.\n   * Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n   * Decompensated liver disease, acute or chronic active hepatitis.\n   * Unstable or active peptic ulcer disease, or patients with gastrointestinal bleeding.\n   * Poorly controlled diabetes mellitus (fasting blood glucose \\>10 mmol\u002FL).\n   * Urinalysis indicating urine protein ≥ ++ and confirmed 24-hour urine protein quantification \\>1.0 g.\n   * Uncontrolled hypercalcemia (\\>1.5 mmol\u002FL ionized calcium, or calcium \\>12 mg\u002FdL, or corrected serum calcium \\> ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy.\n   * Non-healing wound(s) or fracture(s).\n   * Psychiatric disorder that compromises the ability to comply with the treatment protocol.\n10. Female subjects who are pregnant or breastfeeding.\n11. Assessed by the investigator as being unable or unwilling to comply with the requirements of the study protocol.\n12. Known allergy to any of the study drug(s) used in this trial.","70 Years",{"count":78,"type":20},88,[23],"This is a prospective, non-randomized, open-label, single-center phase II clinical trial. It aims to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (ODST) to guide personalized systemic therapy for patients with unresectable biliary tract cancers (BTC). A total of 88 eligible patients will be enrolled and grouped based on patient preference into either the ODST-guided group or the control group (standard therapy). Tumor tissues obtained via biopsy will be used to establish organoid cultures. Drug sensitivity testing will be performed on a panel of approved regimens (including GC, GEMOX, Durvalumab+GC, Pembrolizumab+GC, and Toripalimab+Lenvatinib+GEMOX) to identify the most effective treatment. Patients for whom organoid testing fails or results are unavailable within one month will receive standard therapy. The primary endpoints are Objective Response Rate (ORR) and Progression-Free Survival (PFS). Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel, personalized treatment strategy to improve outcomes for patients with advanced BTC.",[26],[83,84],"organoid","drug-sensitive test","2026-01-10",{"date":87,"type":36},"2026-01-20",{"date":89,"type":20},"2026-01-30",{"date":91,"type":20},"2027-12-31",{"name":93,"class":43},"Eastern Hepatobiliary Surgery Hospital"]