[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-tract-cancers-btc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-tract-cancers-btc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,65,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":39,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100627888","trace-btc-relation-of-biomarkers-and-patients-reported-quality-of-life-to-outcomes-in-patients-with-biliary-tract-cancer-a-real--world-cohort-100627888",false,"NCT07454486","TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort","TRACE-BTC","Inclusion Criteria:\n\n* Histopathologically verified biliary tract cancer (BTC) and\u002For Multidisciplinary Team (MDT) conference decision to define the patient as suffering from BTC.\n* Eligible for curative, adjuvant, or palliative oncological treatment.\n* Age ≥ 18 years.\n* Written and oral consent.\n\nExclusion Criteria:\n\n* Other malignant diseases within 5 years of BTC diagnosis, excluding early-stage non-melanoma skin cancer and carcinoma in situ of the cervix.\n* Conditions that prohibit blood sampling.\n* Known or suspected non-compliance.","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","5 Years","OBSERVATIONAL","Purpose of the Study:\n\nBile duct cancers are rare and aggressive. About 250 new cases are diagnosed each year in Denmark. These cancers are difficult to detect early, so only about 20% of patients can have surgery when diagnosed. Even after surgery, the cancer often returns, and chemotherapy only slightly reduces the risk of relapse.\n\nFor patients who cannot have surgery, treatments such as chemotherapy (sometimes combined with immunotherapy) can relieve symptoms and extend life, but their effect is limited. A small number of patients have specific genetic changes in their cancer that can be treated with targeted medicines.\n\nCurrently, doctors cannot predict which patients will benefit from treatment. Standard monitoring methods like CT scans are expensive, inconvenient, and sometimes unreliable because bile ducts are hard to see clearly on scans.\n\nBlood tests that detect cancer DNA in the blood (called circulating tumor DNA or ctDNA) and other biological markers may be a better way to monitor the disease and adjust treatment. These tests could help detect cancer recurrence earlier and determine whether treatment is working. Measuring patients' quality of life and symptoms over time may also help predict treatment benefit and evaluate effectiveness.\n\nThe goal of this study is to:\n\n* Investigate how biomarkers, including ctDNA, can predict disease course, detect relapse, and monitor treatment response.\n* Identify the best way to measure ctDNA in patients with bile duct cancer.\n* Examine whether patients' own reports of quality of life and symptoms can help assess treatment effect and prognosis.\n\nStudy Design and Procedures:\n\nThis is a prospective cohort study focusing on blood biomarkers and patient-reported symptoms and quality of life.\n\nParticipants agree to provide blood samples:\n\n* Before treatment\n* During treatment\n* During follow-up\n\nEach sample involves up to 40 ml of blood, with a maximum of 20 samples per patient.\n\nThe blood will be analyzed for:\n\n* ctDNA and genetic changes\n* Cancer-related markers\n* Inflammation markers\n* Immune system markers\n\nTumor tissue samples will also be examined to compare blood and tissue results. Full genome or exome sequencing will not be performed. Samples will be stored in a research biobank.\n\nFor patients with incurable disease, quality of life and symptom burden will be monitored repeatedly using Danish questionnaires.\n\nParticipants:\n\nThe study will include:\n\n* Up to 100 patients with potentially curable disease\n* Up to 200 patients with incurable disease\n\nTo participate, patients must:\n\n* Have confirmed bile duct cancer\n* Be eligible for curative, additional (adjuvant), or palliative treatment\n* Be over 18 years old\n* Provide written and verbal consent\n\nPatients cannot participate if they:\n\n* Had another cancer within the past 5 years (except early skin cancer or very early cervical cancer)\n* Cannot safely provide blood samples\n* Are unable to cooperate with study procedures\n\nRisks and Inconveniences:\n\nParticipants will have extra blood samples taken, usually during regular hospital visits. Possible side effects include mild soreness or small bruises at the needle site. The extra blood amount (40 ml per sample) is considered medically insignificant.\n\nParticipants will also spend time filling out questionnaires. The number and frequency of questions have been kept as low as possible while still providing meaningful data.\n\nFinancial Information:\n\nExtra costs for blood sampling, laboratory analysis, and data collection will be covered by external research funding managed by Aarhus University Hospital.\n\nThe researchers have no financial interest in the project. Patients will not receive financial compensation for participating.\n\nRecruitment and Consent:\n\nPotential participants are identified during routine clinical care. During a planned meeting with a doctor, patients receive written and verbal information about the study, including its purpose, risks, advantages, and disadvantages.\n\nThe conversation takes place in a calm and private setting. Patients may bring a support person. They have time to ask questions and at least 24 hours to consider participation.\n\nPatients can withdraw their consent at any time without affecting their treatment. Consent must be given before any study-related procedures begin.\n\nPublication of Results:\n\nThe results - whether positive or negative - will be presented at national and international conferences and submitted to peer-reviewed scientific journals.\n\nEthical Considerations:\n\nAll participants receive standard medical treatment. The risks and disadvantages are limited, and participants are unlikely to benefit directly from the study. However, the research may improve how biomarkers and patient-reported outcomes are used to predict prognosis and treatment response, potentially leading to better treatment for future patients with bile duct cancer.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38],"Biliary Tract Cancer (BTC)","Biliary Tract Cancer (CCA)","Gall Bladder Cancer","Biliary Tract Cancers (BTC)","Cholangiocarcinoma","Cholangiocarcinoma Non-resectable","Cholangiocarcinoma Resectable","Cholangiocarcinoma Metastatic","Cholangiocarcinoma of the Bile Duct","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Hilar","Cholangiocarcinoma, Intrahepatic","Cholangiocarcinoma, Perihilar","Cholangiocarcinoma; Liver",[40,29,41,42,43,44,45,46,47,48,49,50,51],"Biliary Tract Neoplasms","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Gallbladder Neoplasms","Circulating Tumor DNA","Liquid Biopsy","Minimal Residual Disease","Biomarkers, Tumor","Observational Study","Biobanking","DNA Methylation","Precision Oncology","NOT_YET_RECRUITING","2026-03-02",{"date":55,"type":56},"2026-03-06","ACTUAL",{"date":58,"type":20},"2026-03-15",{"date":60,"type":20},"2031-12-30",{"name":62,"class":63},"Aarhus University Hospital","OTHER",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":64},"100623569","phase-2-cosiporfin-sodium-for-injection-photodynamic-therapy-100623569","NCT07398339","Cosiporfin Sodium for Injection Photodynamic Therapy","A Multicenter, Open-Label, Phase IIa Clinical Study Evaluating the Preliminary Efficacy and Safety of Sodium Porphyrin Injection Combined With Photodynamic Therapy Plus Gemcitabine and Cisplatin Chemotherapy in Patients With Advanced Extrahepatic Cholangiocarcinoma With Biliary Obstruction","DVDMS","Inclusion Criteria:\n\n* Subjects must meet all of the following inclusion criteria to be enrolled in this study:\n\n  1. All subjects or their legal representatives must voluntarily sign an ethics committee-approved informed consent form in writing prior to initiating any screening procedures;\n  2. Age ≥ 18 years, no gender restrictions;\n  3. Patients with histologically or cytologically confirmed, locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable or unwilling to undergo surgery;\n  4. No prior systemic therapy during the recurrent or metastatic stage;\n  5. Presence of obstructive lesions in the extrahepatic bile ducts, with at least one measurable lesion outside the bile ducts according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;\n  6. Subjects with an ECOG performance status score of 0 or 1 (see Appendix 3 for details);\n  7. Subjects with an expected survival of ≥3 months;\n  8. Subjects with adequate organ and bone marrow function meeting the following laboratory criteria:\n\n     * Bone marrow function: Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL (1500\u002Fmm³) ; platelets ≥100 × 10⁹\u002FL (1 × 10⁵\u002Fmm³); hemoglobin ≥9.0 g\u002FdL (no treatment for bone marrow suppression, such as GCS-F, EPO, or blood transfusion, within 14 days prior to screening laboratory tests);\n     * Renal Function: Creatinine clearance (Ccr) ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula; see Appendix 4);\n     * Coagulation Function: International Normalized Ratio (INR) ≤1.5 × ULN; Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN;\n     * Echocardiogram: Left ventricular ejection fraction (LVEF) ≥50%;\n     * 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \\\u003C470 msec (Appendix 4);\n  9. Recovered from all prior treatments with toxicities resolved to Grade 1 or below;\n  10. Female subjects of childbearing potential and all male subjects must agree to use highly effective contraception during the trial and for 6 months after the last dose of sodium porphyrin. contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptives, subcutaneous implant, etc.), and women of childbearing potential must have a negative pregnancy test result within ≤7 days prior to study drug administration.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria are ineligible for enrollment:\n\n  1. Patients with ampullary cancer;\n  2. Known hypersensitivity to sodium porphyrin or other photosensitizing agents;\n  3. Diffuse liver metastases or liver tumor burden exceeding 50% of liver volume;\n  4. Known or suspected brain metastases, leptomeningeal metastases, or spinal cord compression (including asymptomatic cases and those adequately treated);\n  5. Subjects who participated in any other drug clinical trial or other interventional clinical trial within 4 weeks prior to study drug administration, except for subjects participating in observational (non-interventional) clinical studies or those already in the follow-up period of an interventional study;\n  6. Previous exposure to photosensitizers or photodynamic therapy;\n  7. Patients with unremovable stents in the extrahepatic bile ducts;\n  8. Patients with prior history of immunotherapy (including but not limited to various anti-PD-1 monoclonal antibodies, anti-PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies, etc.), gemcitabine, or cisplatin treatment;\n  9. Subjects who underwent major surgery within 4 weeks prior to study drug administration;\n  10. Subjects who used Chinese herbal medicines with immunomodulatory or antitumor effects within 14 days prior to study drug administration;\n  11. Subjects with advanced cholangiocarcinoma in a cachectic state or who are not expected to tolerate photodynamic therapy;\n  12. Patients with Bismuth Type IV hilar cholangiocarcinoma;\n  13. Individuals unsuitable for ERCP or endoscopic procedures;\n  14. Subjects requiring concomitant antitumor therapy during study drug treatment, including chemotherapy regimens other than GC, radiotherapy, immunotherapy, or biologic agents;\n  15. Any other malignancy diagnosed within 5 years prior to the first study drug administration, except for any type of carcinoma in situ, micro- or low-risk papillary thyroid carcinoma, and cured basal cell carcinoma or squamous cell carcinoma of the skin;\n  16. History of allogeneic organ transplantation, or known history of autologous or allogeneic hematopoietic stem cell transplantation;\n  17. Presence of clinically significant (malignant\u002Fcancerous, or moderate to large volume) pleural effusion, ascites, or pericardial effusion within 4 weeks prior to the first dose of porphyrin sodium; however, subjects with only small amounts of effusion (untreated) identified by imaging may be eligible;\n  18. Presence of acute inflammation (especially necrotizing inflammation) or clinically significant active infection;\n  19. Hepatitis C virus (HCV) RNA positive, active syphilis, or positive results for any one or more of the following: human immunodeficiency virus (HIV) antibody test, or active hepatitis B (defined as HBV DNA ≥ 2000 IU\u002FmL or HBV DNA ≥ 10⁴ copies);\n  20. Clinically significant cardiovascular disease or conditions, including but not limited to:\n\n      1. Myocardial infarction within 6 months prior to first dosing;\n      2. Uncontrolled angina pectoris within 3 months prior to first dosing;\n      3. History or current presence of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes) or other ≥ Grade 2 persistent arrhythmias (per NCI-CTCAE v5.0);\n      4. History or current presence of congestive heart failure \\[New York Heart Association (NYHA) Class III or IV (Appendix 5)\\];\n      5. Complete left bundle branch block or complete right bundle branch block with left anterior fascicular block (double bundle branch block);\n      6. Long QT syndrome or confirmed family history of long QT syndrome; known concomitant use of QT-prolonging medications;\n      7. Bradycardia, defined as a screening ECG showing a heart rate \\\u003C 45 beats per minute;\n      8. Hypotension, defined as a screening systolic blood pressure ≤86 millimeters of mercury (mmHg);\n      9. Uncontrolled hypertension, where the subject receives standard antihypertensive therapy but has a screening systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg;\n  21. Cerebrovascular events (including hemorrhagic, ischemic, transient ischemic attacks), cranial surgery, or unexplained loss of consciousness within 6 months prior to the first dose;\n  22. Severe pre-existing conditions such as interstitial lung disease, severe dyspnea occurring at rest or requiring supplemental oxygen, inability to lie flat due to acute asthma exacerbation or respiratory failure, active or chronic liver disease, severe hepatic impairment \\[Child-Pugh Class C\\], hemorrhagic disorders secondary to hepatic insufficiency, hepatic encephalopathy, etc.; epilepsy or conditions likely to induce seizures; diseases requiring systemic immunosuppressive therapy \\[including immunosuppressants such as anti-TNF monoclonal antibodies, glucocorticoids (nasal inhalation or topical application permitted)\\]; history of adrenal insufficiency;\n  23. Thromboembolic disease within 6 months prior to first dose;\n  24. Uncontrolled psychiatric illness\u002Fsocial circumstances expected to limit compliance with study requirements or impair the subject's ability to provide written informed consent;\n  25. Known history of psychiatric drug abuse or substance abuse;\n  26. Pregnant or lactating women;\n  27. Receipt of a live vaccine within 4 weeks prior to the first dose;\n  28. Other reasons deemed by the investigator to make the subject unsuitable for participation in this trial.",{"count":74,"type":20},30,"INTERVENTIONAL",[77],"PHASE2","Study Design: Multicenter, open-label, Single Group Study Population: Patients with locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable or unwilling to undergo surgery.\n\nPrimary Research Objective: To preliminarily evaluate the efficacy of photodynamic therapy (PDT) with sodium protoporphyrin combined with gemcitabine and cisplatin (GC regimen) chemotherapy in patients with advanced extrahepatic cholangiocarcinoma complicated by biliary obstruction.\n\nSecondary Study Objective: To preliminarily evaluate the safety and tolerability of photodynamic therapy (PDT) with heme porphyrin sodium combined with gemcitabine and cisplatin (GC regimen) chemotherapy in patients with advanced extrahepatic cholangiocarcinoma with biliary obstruction.\n\nPrimary endpoint: 6-month overall survival rate (6m-OS rate)",[28],"RECRUITING","2026-02-04",{"date":83,"type":56},"2026-02-09",{"date":85,"type":20},"2026-03-31",{"date":87,"type":20},"2028-03-31",{"name":89,"class":90},"Shanghai Guangsheng Biopharmaceutical Co., Ltd","INDUSTRY",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":75,"phases":101,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":64},"100563067","a-study-of-tumor-treating-fields-in-combination-with-durvalumab-and-gemcitabinecisplatin-in-biliary-tract-cancers-100563067","NCT06611345","A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine\u002FCisplatin in Biliary Tract Cancers","A Single-Arm, Phase 1b Study to Assess Tumor-Treating Fields (TTF) in Combination With Durvalumab and Gemcitabine\u002FCisplatin (GemCis) as the First-Line Treatment of Unresectable Biliary Tract Cancers (BTC)","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent for the trial.\n2. Male or female patients between the ages of 18 and 75 years (including 18 and 75 years).\n3. Body weight \\> 30 kg.\n4. Histologically confirmed, unresectable adenocarcinoma of the biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.\n5. Patients with the previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.\n6. Patients with recurrent disease \\>6 months after curative surgery or \\>6 months after the completion of adjuvant therapy (chemotherapy and\u002For radiation) will be eligible (but he\u002Fshe does not receive systemic treatment as the first-line therapy).\n7. At least 1 measurable lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.\n8. ECOG PS of 0 or 1.\n9. Life expectancy ≥12 weeks at the time of screening.\n10. No prior exposure to immune-mediated therapy, including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines.\n11. Patients must have adequate organ function as indicated by the following laboratory values: Hemoglobin ≥9.0 g\u002FdL; Absolute neutrophil count ≥1.5 ×109\u002FL; Platelet count ≥100 ×109\u002FL. No blood transfusion, granulocyte colony-stimulating factor (G-CSF), filgrastim and other drugs are used within 2 weeks before the examination. Serum bilirubin ≤2.0 × the upper limit of normal (ULN); This will not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction should be resolved before treatment. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤5 × ULN. Creatinine clearance (CL) \\>50 mL\u002Fmin per 24-hour urine or as calculated by Cockroft and Gault formula (using actual body weight).\n12. Patients (women of childbearing potential and males with fertile female partners) must be willing to use the currently accepted reliable contraception method from the time of screening throughout the total duration of the study treatment and the drug washout period (180 days after the last dose of GemCis or 90 days after the last dose of durvalumab monotherapy). These measures include, but are not limited to, oral or implantable injections of hormonal contraceptives; intrauterine birth control ring or placement of IUS intrauterine device); or use of barrier methods such as condoms or septum and spermicide products. Postmenopausal women over 50 years of age must have been amenorrheic for at least 12 months to be considered non-childbearing potential.\n13. Patients with HBV infection (as characterized by positive hepatitis B surface antigen \\[HBsAg\\] and\u002For anti-hepatitis B core antibodies (anti-HBc) with detectable HBV deoxyribonucleic acid (DNA) \\[above the limit of detection per local laboratory\\]) must receive antiviral therapy prior to treatment per institutional practice to ensure adequate viral suppression. Patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study treatment. Patients who test positive for anti-HBc with undetectable HBV DNA (under the limit of detection per local laboratory) do not require antiviral therapy unless HBV DNA reaches detectable limits per local laboratory during the course of treatment. Patients with active co-infection of HBV and HCV as evidenced by positive anti-HCV antibody and actively co-infected with HBV and hepatitis D virus are not eligible.\n14. Able to operate TTF device independently or with the help of a caregiver.\n\nExclusion Criteria:\n\n1. Patients previously received systemic treatment as the first-line therapy.\n2. Ampullary carcinoma.\n3. History of allogeneic organ transplantation.\n4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion: Patients with vitiligo or alopecia; Patients with hypothyroidism (e.g., following Hashimoto syndrome) are stable on hormone replacement; Any chronic skin condition that does not require systemic therapy; Patients without active disease in the last 5 years may be included but only after consultation with the investigator\u002F Study Physician; Patients with celiac disease controlled by diet alone.\n5. Uncontrolled intercurrent illness, including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase the risk of incurring AEs, or compromise the ability of the patient to give written informed consent.\n6. History of another primary malignancy, except for: Malignancy was treated with curative intent and with no known active disease ≥5 years before the first dose of the investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated carcinoma in situ without evidence of disease.\n7. History of leptomeningeal carcinomatosis.\n8. History of active primary immunodeficiency.\n9. Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), or human immunodeficiency virus (positive HIV 1\u002F2 antibodies).\n10. Any unresolved toxicity NCI CTCAE Grade ≥2 from a previous anticancer therapy, with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.\n11. Brain metastases or spinal cord compression (including asymptomatic and adequately treated disease). Patients with suspected brain metastases at screening should have an MRI (preferred) or CT scan, each preferably with IV contrast of the brain prior to study entry.\n12. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n13. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n14. Radiation therapy, including palliative radiation, is not allowed before the study, with an exception of radiation given in an adjuvant setting.\n15. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note that patients, if enrolled, should not receive a live vaccine while receiving IP and up to 30 days after the last dose of IP.\n16. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note that minor surgery of isolated lesions for palliative intent is acceptable if performed more than 14 days prior to the first dose of IP.\n17. Patients who have received prior immune-mediated therapy, including, but not limited to, other anti-PD-1, anti-PD-L1, or anti-CTLA-4.\n18. Prior locoregional therapy such as radioembolization.\n19. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: Intranasal, inhaled, or topical steroids, or local steroid injections (e.g., intra-articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n20. Participation in another clinical study with an IP administered in the last 3 months.\n21. Previous IP assignment in the present study.\n22. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n23. Prior randomization or treatment in a previous durvalumab clinical study, regardless of treatment arm assignment.\n24. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to use effective birth control from screening to 180 days after the last dose of GemCis or 90 days after the last dose of durvalumab monotherapy.\n25. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.\n26. Active infection of hepatitis C as evidenced by detectable HCV RNA per local laboratory. Patients who test positive for hepatitis C (HCV) antibody may be enrolled if HCV RNA is undetectable.\n27. Known allergy or hypersensitivity to medical adhesives or hydrogel.\n28. Implantable electronic medical devices such as cardiac pacemakers.\n29. Metallic medical devices, such as bone nails, were implanted in the chest and abdomen.\n30. Patients with infection, ulcer or unhealed wound at the electrode application site.\n31. Patients with symptomatic ascites, pleural effusion, pericardial effusion, etc., unless the condition is well controlled after clinical treatment (including therapeutic puncture).","75 Years",{"count":100,"type":20},60,[102],"NA","Unresectable BTC represents an area of unmet medical need due to its very aggressive nature, limited treatment options, and poor prognosis. This study is to evaluate the efficacy and safety of adding TTF to the established regimen of durvalumab plus GemCis for the treatment of patients with previously untreated, unresectable BTC.",[28],"2024-10-24",{"date":107,"type":56},"2024-10-26",{"date":109,"type":56},"2024-10-21",{"date":111,"type":20},"2027-03-30",{"name":113,"class":90},"Jiangsu Healthy Life Innovation Medical Technology Co., Ltd"]