[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CHA University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":325},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,46,79,101,128,145,167,194,222,244,272,300],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652439","phase-2-atezolizumab-bevacizumab-and-tocilizumab-in-advanced-hepatocellular-carcinoma-100652439",false,"NCT07774247","Atezolizumab, Bevacizumab, and Tocilizumab in Advanced Hepatocellular Carcinoma","A Multicenter, Phase II Study to Evaluate the Safety and Efficacy of Atezolizumab, Bevacizumab, and Tocilizumab in Patients With Advanced Hepatocellular Carcinoma","AB-TCZ","Inclusion Criteria:\n\n1. Histologically, cytologically, or radiologically confirmed diagnosis of locally advanced, metastatic, and\u002For unresectable hepatocellular carcinoma (HCC).\n2. Age ≥19 years at the time of signing the informed consent form (ICF).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study drug.\n4. Child-Pugh class A (score 5-6) within 7 days prior to the first dose of study drug.\n5. Disease not amenable to curative surgical and\u002For locoregional therapy.\n\n   \\- Patients who have experienced disease progression after prior surgical and\u002For locoregional therapy are eligible.\n6. Ability to provide written informed consent prior to initiation of any study-specific procedures, including agreement to comply with the requirements and restrictions listed in this protocol.\n7. No prior systemic therapy for hepatocellular carcinoma, including investigational agents.\n\n   \\- Prior use of herbal or traditional medicines with known or potential anticancer activity is permitted only if discontinued prior to initiation of study treatment.\n8. Estimated life expectancy of at least 3 months.\n9. At least one measurable lesion according to RECIST version 1.1.\n\n   \\- Patients who have received prior locoregional therapy (e.g., radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, or transarterial embolization) are eligible if the target lesion has not been previously treated or if the lesion has demonstrated progression within the treated area per RECIST v1.1.\n10. Adequate hematologic and organ function, as defined by the following laboratory values obtained within 7 days prior to the first dose of study drug (no blood transfusion or albumin administration within 2 weeks prior to or during screening to meet eligibility criteria).\n\n    * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (≥1500\u002FμL)\n    * Lymphocyte count ≥ 0.5 x 109\u002FL (≥500\u002FμL)\n    * Platelet count ≥ 100 x 109\u002FL (≥100,000\u002FμL)\n    * Hemoglobin ≥ 90 g\u002FL (≥9.0 g\u002FdL)\n    * AST, ALT, and ALP ≤ 5 x ULN\n    * Total bilirubin ≤ 3 x ULN\n    * Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n    * Albumin ≥ 28 g\u002FL (≥2.8 g\u002FdL)\n    * For patients not receiving anticoagulants: INR or aPTT ≤1.5 x ULN, patients receiving low-molecular-weight heparin are eligible.\n11. Documented hepatitis virus status based on screening tests for HBV and HCV.\n\n    * For patients with active HBV infection: HBV DNA \\\u003C500 IU\u002FmL during screening, initiation of antiviral therapy at least 14 days prior to the first dose of study drug, and willingness to continue antiviral therapy throughout the study.\n    * For patients with active or prior HCV infection: negative HCV RNA (PCR).\n    * Patients with co-infection of HBV and HCV are not eligible.\n12. Reproductive status:\n\n    * Female patients must not be pregnant or breastfeeding.\n    * Negative serum pregnancy test within 72 hours prior to the first dose of study drug.\n    * Female patients must agree not to breastfeed from the time of consent until at least 6 months after the last dose of study drug.\n    * Females of childbearing potential and non-sterilized males must agree to use two effective methods of contraception during the study and for at least 6 months after the last dose.\n13. Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiogram or MUGA scan, with no severe valvular disease or clinically significant arrhythmia.\n14. Corrected QT interval using Fridericia's formula (QTcF) ≤470 msec.\n15. Willingness to provide blood samples.\n\nExclusion Criteria:\n\n1. Prior systemic therapy for locally advanced, metastatic, and\u002For unresectable hepatocellular carcinoma, including chemotherapy, biologic therapy, immunotherapy, hormonal therapy, or investigational agents.\n\n   \\- Prior adjuvant therapy is permitted if disease recurrence occurred at least 6 months after completion of the last treatment, including adjuvant therapy and radiotherapy.\n2. Presence of multiple primary malignancies.\n\n   \\- Exceptions include completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or other malignancies with no recurrence for ≥5 years.\n3. Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed hepatocellular-cholangiocarcinoma.\n4. Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding: Patients must undergo esophagogastroduodenoscopy (EGD) prior to enrollment, and all varices must be evaluated and treated according to institutional standard of care. If evaluation has been performed within 6 months prior to the first dose of study drug, repeat evaluation is not required.\n5. Residual toxicities from prior therapy that, in the investigator's opinion, may interfere with safety evaluation of the study drug, or patients for whom the possibility of surgical resection cannot be completely excluded at the time of enrollment.\n6. History of severe hypersensitivity reactions to other monoclonal antibody products.\n\n   * Prior exposure to or hypersensitivity to anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 antibodies, or other agents targeting T-cell regulation.\n   * Known hypersensitivity or allergy to atezolizumab, bevacizumab, or tocilizumab.\n7. Active autoimmune disease or a history of chronic or recurrent autoimmune disease, or use of systemic immunosuppressive medications within 2 weeks prior to the first dose of study drug.\n\n   * Patients with hypothyroidism requiring only hormone replacement therapy, vitiligo, psoriasis not requiring systemic treatment, or other conditions deemed stable and safe by the investigator may be eligible.\n   * Patients with primary or secondary immunodeficiency or active immunodeficiency are excluded.\n8. Current or prior history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings.\n\n   \\- Patients with radiation pneumonitis may be eligible if clinically stable (beyond the acute phase) without concern for recurrence.\n9. Known central nervous system (CNS) metastases.\n10. Presence of clinically significant pericardial effusion, pleural effusion, or ascites requiring treatment.\n11. Uncontrolled tumor-related pain: patients requiring chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control during study treatment are excluded.\n12. History of transient ischemic attack or cerebrovascular accident within 180 days prior to enrollment.\n13. History of significant cardiovascular disease, including any of the following:\n\n    * Myocardial infarction within 180 days prior to enrollment.\n    * Uncontrolled angina within 180 days prior to enrollment\n    * Congestive heart failure classified as New York Heart Association (NYHA) Class III or IV.\n    * Uncontrolled hypertension despite appropriate medical management (e.g., systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg persisting for ≥24 hours).\n    * Arrhythmia requiring treatment.\n    * Significant vascular disease, including recent peripheral arterial thrombosis or aneurysm requiring surgical intervention.\n14. Uncontrolled diabetes mellitus.\n15. Systemic infection requiring treatment within 14 days prior to the first dose of study drug and treated with intravenous antibiotics (prophylactic use of oral antibiotics is permitted).\n16. Use of systemic corticosteroids (\\>10 mg\u002Fday of prednisolone or equivalent) or other immunosuppressive medications within 28 days prior to the first dose of study drug (excluding short-term use for diagnostic, prophylactic, or similar purposes).\n17. Patients who received anticancer therapy (e.g., cytotoxic chemotherapy, targeted therapy, immunotherapy) within 28 days prior to the first dose of study drug.\n\n    \\- Adjuvant therapy completed more than 6 months prior is permitted.\n18. Pleurodesis or pericardiodesis within 28 days prior to the first dose of study drug.\n19. Current or recent (within 2 weeks) use of aspirin (\\>325 mg\u002Fday) or antiplatelet agents such as clopidogrel, dipyridamole, ticlopidine, or cilostazol for therapeutic purposes: prophylactic anticoagulation is permitted if INR \\\u003C1.5 × ULN and aPTT is within normal limits.\n20. Major surgery under general anesthesia within 28 days prior to the first dose of study drug.\n21. Surgery under local anesthesia within 14 days prior to the first dose of study drug.\n22. Palliative radiotherapy within 28 days prior to the first dose of study drug, or radiotherapy to bone metastases within 14 days prior to the first dose.\n23. Positive test for any of the following:\n\n    \\- HIV-1 antibody, HIV-2 antibody.\n24. Pregnant or breastfeeding patients, or those with a possibility of pregnancy or plans to become pregnant.\n25. Patients who received unapproved or investigational agents (e.g., investigational drugs, unapproved drug combinations, or unapproved formulations) within 28 days prior to enrollment.\n26. Patients deemed unable to provide informed consent due to comorbid conditions such as dementia.\n27. Patients unable or unwilling to sign the informed consent form.\n28. Known pre-existing central nervous system demyelinating disorders or seizure disorders.\n29. Known active diverticulitis, chronic ulcerative lower gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis), or other symptomatic lower gastrointestinal conditions that may predispose patients to gastrointestinal perforation.\n30. Current active infection or history of recurrent infections, including but not limited to tuberculosis, atypical mycobacterial infection, herpes zoster, or other bacterial, viral, fungal, or mycobacterial infections (excluding fungal nail bed infections).","ALL","19 Years",{"count":20,"type":21},51,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2, open-label, single-arm, multicenter study designed to evaluate the safety and efficacy of atezolizumab, bevacizumab, and tocilizumab in patients with locally advanced, metastatic, and\u002For unresectable hepatocellular carcinoma (HCC). Approximately 51 patients will be enrolled at 6 study sites and will receive combination therapy consisting of atezolizumab, bevacizumab, and tocilizumab. Patients assigned to the study will receive atezolizumab 1,200 mg intravenously and bevacizumab 15 mg\u002Fkg intravenously on Day 1 of each 21-day cycle, alongside tocilizumab 4 mg\u002Fkg intravenously on Day 1 of each 42-day cycle for up to 5 doses. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. The study population includes adult patients with locally advanced, metastatic, and\u002For unresectable HCC who have received no prior systemic therapy for hepatocellular carcinoma. Eligible patients must have histologically, cytologically, or radiologically confirmed diagnosis, at least one measurable lesion according to RECIST version 1.1, Child-Pugh class A liver function, ECOG performance status 0 or 1, and adequate organ function. The primary objective is to assess the incidence of Grade 3 or higher immune-related adverse events (irAEs) occurring within 24 weeks after treatment initiation according to NCI CTCAE version 5.0. Secondary objectives include evaluation of objective response rate (ORR) and disease control rate (DCR) according to RECIST v1.1, progression-free survival, overall survival, and the rate of treatment discontinuation due to adverse events. Safety evaluations will include assessment of adverse events, serious adverse events, laboratory parameters, vital signs, and other clinical assessments. Exploratory objectives include evaluation of the correlation between treatment response and serum inflammatory markers (such as IL-6 and CRP) and immune cell profiles using blood samples collected at protocol-defined intervals. Tumor assessments will be performed at protocol-defined intervals using radiologic imaging every 6 weeks from Cycle 1 Day 1 up to Week 54, and every 9 weeks thereafter. The primary efficacy analysis will be based on the Full Analysis Set according to RECIST v1.1. This study is intended to evaluate the clinical activity and safety profile of prophylactic tocilizumab in combination with atezolizumab and bevacizumab in this patient population and to generate data to inform future clinical development.",[27],"Hepatocellular Carcinoma (HCC)",[29,30,31,32],"HCC","IL-6","Immunotherapy","Tocilizumab","NOT_YET_RECRUITING","2026-08-14",{"date":36,"type":37},"2026-08-19","ACTUAL",{"date":39,"type":21},"2026-09-01",{"date":41,"type":21},"2029-09-01",{"name":43,"class":44},"CHA University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100595087","the-rule-out-acute-myocardial-infarction-using-aritifical-intelligence-electrocardiogram-romiae-2-trial-100595087","NCT07027891","The Rule-Out Acute Myocardial Infarction Using Aritifical Intelligence Electrocardiogram (ROMIAE) 2 Trial","ROMIAE 2 Trial: Randomized Controlled Trial for Managing Suspicious Acute Myocardial Infarction in ED Using AI-ECG","ROMIAE 2","Inclusion Criteria:\n\n* chest pain\n* suspicious of acute myocardial infarction\n\nExclusion Criteria:\n\n* STEMI\n* Revisit of same symptoms within 1 week\n* traumatic chest pain\n* Pneumothorax\n* Transferred from other hospital diagnosed of AMI\n* Cardiac arrest\n* Chest pain of clearly non-cardiac etiology\n* declined to participate in the study","18 Years",{"count":56,"type":21},4670,[58],"NA","This study is to see whether the AI ECG assisted protocol is as safe and efficacious as conventional protocol in early triage of suspected myocardial infarction.",[61,62],"Myocardial Infarction (MI)","Chest Pain Rule Out Myocardial Infarction",[64,65,66,67,68,69],"chest pain, suspicious myocardial infarction","artificial intelligence","electrocardiogram","emergency department","acute coronary syndrome","AI\u002FML-enabled SaMd","RECRUITING","2026-07-26",{"date":73,"type":37},"2026-07-28",{"date":75,"type":37},"2025-07-01",{"date":77,"type":21},"2028-02-28",{"name":43,"class":44},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":45},"100630899","phase-2-fostrox-plus-lenvatinib-vs-lenvatinib-in-advanced-hepatocellular-carcinoma-after-first-line-immunotherapy-100630899","NCT07493668","Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy","A Phase 2, Multicenter, Randomized, Open-label Study Comparing Fostrox + Lenvatinib vs. Lenvatinib in Patients With Locally Advanced or Unresectable Advanced Hepatocellular Carcinoma (HCC) Who Have Received First-line Combination Immunotherapy","FLEX-HCC","Inclusion Criteria:\n\n1. Patients with a diagnosis of locally advanced or unresectable metastatic HCC confirmed by radiology, histology, or cytology\n2. Received at least 2 cycles of first-line systemic therapy with immunotherapy (IO) combination (atezolizumab + bevacizumab, ipilimumab + nivolumab, or durvalumab + tremelimumab), with radiologically confirmed disease progression\n3. Patients with measurable lesion in the liver (at least one target lesion) according to RECIST v1.1 and mRECIST\n\n   \\- Patients who received prior local therapy (e.g., radiofrequency ablation, cryoablation, percutaneous ethanol or acetic acid injection, high-intensity focused ultrasound, transarterial chemoembolization, or transarterial embolization) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST v1.1\n4. Patients who are not amenable for curative surgery or locoregional therapy\n5. ECOG performance status of 0 or 1 within 7 days prior to randomization\n6. Life expectancy of at least 3 months\n7. Subjects age ≥19 years at the time of signing the informed consent form (ICF)\n8. Subjects who are capable of providing signed informed consent to comply with requirements and limitations described in the ICF and this protocol and express obvious and voluntary agreement prior to the start of the study\n9. Subjects with adequate hematological function and hepatic function without using blood transfusion or growth factors within 7 days prior to randomization\n\n   * Hemoglobin (Hb) ≥9.0 g\u002FdL\n   * Absolute neutrophil count (ANC) ≥1,500\u002Fμl\n   * Platelet count ≥75,000\u002Fμl\n   * Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) estimated by Cockcroft-Gault equation ≥60 mL\u002Fmin\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5.0 x ULN\n   * Serum total bilirubin ≤3.0 x ULN\n   * International normalized ratio (INR) ≤1.5 or prothrombin time ≤1.5 x ULN\n   * Activated partial thromboplastin time (aPTT) ≤1.5 x ULN\n10. Child Pugh A within 7 days prior to randomization\n11. Negative HIV test at screening\n12. Documented hepatitis virus status for HBV and HCV confirmed at screening\n\n    * For patients with active HBV: HBV DNA \\\u003C500 IU\u002FmL during screening; initiation of antiviral therapy at least 14 days prior to randomization; willingness to continue antiviral therapy during the study\n    * For patients with active or past HCV infection: confirmed negative viral load using HCV PCR\n    * For patients with concurrent HBV and HCV infection: not eligible\n13. Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade ≤1 before participation, except alopecia\n14. Patients with a prior history of gastric or esophageal variceal bleeding may be eligible if they have received appropriate treatment with no evidence of recurrent bleeding for at least 6 months, have no high-risk features on a recent endoscopy, and are currently assessed to be at low risk of bleeding.\n15. Female subjects\n\n    * Eligible if postmenopausal\n    * Female patient who is a woman of childbearing potential (WOCBP) (post menarchal) who agrees to use a highly efficient method of contraception (a method with less than 1% failure rate \\[e.g. sterilization, hormone implants, hormone injections, intrauterine devices, vasectomized partner, or combined birth control pills\\]) from screening until at least 6 months after the last dose of study drug\n    * WOCBP must have a negative urine pregnancy test at screening and negative urine pregnancy test within 72 hours before the first dose of study drug.\n    * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n    * Female patients must agree not to breast feed after the time of consent and for at least 6 months after the administration of the last dose of study drug.\n16. Male subjects\n\n    * Male patient who has had a successful vasectomy (confirmed azoospermia)\n    * Male patient agrees to use effective contraception, including condom use, from screening until at least 3 months after the last dose of study drug (no sperm donation is allowed during the study period and for at least 3 months after study drug discontinuation)\n    * Male patient with a female partner who is a WOCBP and is using a highly efficient method of contraception as described above\n\nExclusion Criteria:\n\n1. Patients who have received more than 1 prior systemic therapy (i.e., fostrox + lenvatinib or lenvatinib must be administered as second-line treatment)\n2. Patients who have received first-line systemic therapy for locally advanced unresectable or metastatic HCC other than an IO combination\n3. Patients who have received a prior TKI (e.g. lenvatinib, regorafenib, cabozantinib etc.) in the IO combination\n4. Patients with a history of hypersensitivity to lenvatinib or any of its components (active ingredient or excipients)\n5. Patients with fibrolamellar HCC, sarcomoid HCC, or a mix of HCC and intrahepatic cholangiocarcinoma (iCCA)\n6. Patients with central nervous system metastasis\n7. Patients with VP4 portal vein tumor thrombosis (PVTT)\n8. Patients with significant cardiovascular disease within 3 months prior to randomization\n\n   * New York Heart Association (NYHA) Class III or IV congestive heart failure\n   * Unstable angina\n   * Myocardial infarction\n   * Cardiac arrhythmia associated with hemodynamic instability\n9. Subjects with Corrected QT interval (QTcF) \\>470 msec at Screening (corrected by Fridericia Formula)\n10. Patients with prior allogeneic stem cell or solid organ transplantation\n11. Patients with systemic infection requiring treatment including active tuberculosis within 14 days prior to the first dose of study drug (prophylactic oral antibiotics are permitted)\n12. Major surgery within 3 weeks prior to randomization or scheduled for surgery during the study\n13. Patients with active malignancy within the past 36 months prior to randomization (except for completed resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in-situ, intramucosal carcinoma, superficial bladder cancer, or other cancers with no recurrence for ≥3 years)\n14. Patients with gastric or esophageal varices that require interventional treatment within 28 days prior to randomization. Prophylaxis with pharmacologic therapy (e.g. nonselective beta-blocker) is permitted.\n15. Patients with bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic INR monitoring (e.g. warfarin etc.). Treatment with low molecular weight heparin and factor X inhibitors which do not require INR monitoring is permitted.\n16. Systolic blood pressure (BP) \\>160 mmHg or diastolic BP \\>100 mmHg despite optimal antihypertensive therapy, or uncontrolled without changes in antihypertensive agents within 1 week prior to screening\n17. Clinical ascites regardless of the severity (mild, moderate, or severe). Radiological ascites managed with diuretics and a low-sodium diet are accepted if the Child-Pugh score is A.\n18. History of encephalopathy within the 6 months prior to randomization or current hepatic encephalopathy\n19. Receiving drugs that are extensively metabolized by CYP3A4 that have a narrow therapeutic index must be discontinued 5 half-lives before the first dose of study drug (fostrox). Information on CYP3A4 was referenced from the following websites:\n\n    * CredibleMeds (https:\u002F\u002Fcrediblemeds.org)\n    * DrugBank (https:\u002F\u002Fgo.drugbank.com\u002Fcategories\u002FDBCAT002646)\n20. Receiving drugs that are strong inhibitors of P-glycoprotein (P-gP) and\u002For breast cancer resistance protein (BCRP)\n21. Proteinuria as defined by urine protein ≥1 g\u002F24 hours at screening. Patients having \\>2+ proteinuria on urine dipstick testing will undergo a 24 hour urine collection or urine protein-to-creatinine ratio (UPCR) test for quantitative assessment of proteinuria.\n22. Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to initiation of study treatment\n23. Receiving anticancer therapy for HCC within 4 weeks prior to the first dose of study drug (fostrox)\n24. Receiving any other investigational agent within 4 weeks prior to screening\n25. Enrolled in another clinical study with an investigational drug\n26. Are unable to swallow orally administered medication or have gastrointestinal disorders likely to interfere with absorption of the study drug\n27. Any other condition that precludes adequate understanding, cooperation, and compliance with study procedures or any condition that could pose a risk to the patient's safety, as per the investigator's judgment",{"count":88,"type":21},80,[24],"This is a Phase 2, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of fostrox in combination with lenvatinib compared with lenvatinib alone in patients with locally advanced or unresectable advanced hepatocellular carcinoma (HCC) who have experienced radiologically confirmed disease progression following first-line combination immunotherapy.\n\nApproximately 80 patients will be enrolled at 9 study sites and randomized in a 1:1 ratio to 1 of 2 treatment arms: fostrox plus lenvatinib or lenvatinib alone. Patients assigned to the investigational arm will receive fostrox orally once daily on Days 1 through 5 of each 21-day cycle in combination with continuous daily lenvatinib. Patients assigned to the control arm will receive lenvatinib alone according to the approved weight-based dosing regimen. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met.\n\nThe study population includes adult patients with locally advanced or unresectable metastatic HCC who have received at least 2 cycles of first-line systemic therapy with an immunotherapy combination and have radiologically confirmed disease progression. Eligible patients must have measurable disease according to RECIST version 1.1 and mRECIST, adequate organ function, and Child-Pugh class A liver function.\n\nThe primary objective is to assess objective response rate (ORR) as determined by an Independent Review Facility (IRF) according to RECIST v1.1. Secondary objectives include evaluation of ORR by investigator assessment according to RECIST v1.1 and mRECIST, duration of response, disease control rate, progression-free survival, time to progression, overall survival, and safety and tolerability. Safety evaluations will include assessment of adverse events, serious adverse events, laboratory parameters, vital signs, and other clinical assessments. Exploratory objectives include evaluation of peripheral blood-based biomarkers, metabolic changes associated with study treatment, collection and storage of DNA and RNA for exploratory analyses, and pharmacokinetic assessment of fostrox and its metabolite troxacitabine in patients receiving fostrox in combination with lenvatinib.\n\nTumor assessments will be performed at protocol-defined intervals using radiologic imaging. The primary efficacy analysis will be based on IRF assessment according to RECIST v1.1. This study is intended to characterize the clinical activity and safety profile of fostrox plus lenvatinib compared with lenvatinib alone in this patient population and to generate data to inform future clinical development.",[27],[29],"2026-05-20",{"date":95,"type":37},"2026-05-22",{"date":97,"type":37},"2026-05-14",{"date":99,"type":21},"2029-04-27",{"name":43,"class":44},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":45},"100604561","ctdna-in-genetic-profiling-and-clinical-outcomes-of-advanced-biliary-tract-cancer-100604561","NCT07151118","ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer","Role of Circulating Tumor DNA (ctDNA) in Genetic Profiling and Clinical Outcomes for Advanced Biliary Tract Cancer (BTC) Patients - Prospective, Observational, Epidemiology Study","Inclusion Criteria:\n\n* Histologically confirmed advanced or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma)\n* Patients meeting one of the following conditions:\n\n  * Prior to initiation of first-line systemic therapy\n  * Patients who previously received systemic therapy and are able to provide a blood sample prior to initiation of subsequent therapy\n* Age ≥ 19 years at the time of enrollment\n* Willingness and ability to provide blood samples for ctDNA analysis\n\nExclusion Criteria:\n\n* Refusal to provide blood samples for ctDNA testing\n* Inability to provide written informed consent",{"count":109,"type":21},100,"OBSERVATIONAL","This prospective, multicenter, observational study aims to evaluate the role of circulating tumor DNA (ctDNA) in advanced or metastatic biliary tract cancer (BTC) patients in Korea. Tissue-based genomic profiling is often limited due to the anatomical challenges of tumor biopsy and insufficient DNA quality. ctDNA analysis offers a minimally invasive alternative for identifying actionable genetic alterations, including Fibroblast Growth Factor Receptor 2 (FGFR2) fusions, Isocitrate Dehydrogenase 1 (IDH1) mutations, and Human Epidermal Growth Factor Receptor 2 (HER2) amplifications. The study will recruit 100 patients across 11 institutions and assess the concordance between ctDNA and tissue genomic profiling, as well as the clinical relevance of ctDNA in predicting treatment outcomes and prognosis.",[113],"Biliary Tract Cancer",[113,115,116,117,118,119],"Biomarker","IDH1 mutation","FGFR2 fusion","Circulating Tumor DNA (ctDNA)","Biomarker Analysis","2026-03-17",{"date":122,"type":37},"2026-03-18",{"date":124,"type":37},"2025-09-01",{"date":126,"type":21},"2027-08-31",{"name":43,"class":44},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":144,"locationsCount":45},"100603877","role-of-ctdna-in-genetic-profiling--outcomes-for-advanced-btc-100603877","NCT07142226","Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC","Role of Circulating Tumor DNA (ctDNA) in Genetic Profiling and Clinical Outcomes for Advanced Biliary Tract Cancer (BTC) Patients - A Multicenter, Prospective, Observational Epidemiology Study","Inclusion Criteria:\n\n* Patients with histologically confirmed advanced or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer).\n* Patients who meet one of the following conditions:\n\n  * Patients prior to initiation of first-line systemic chemotherapy, or\n  * Patients previously treated with systemic chemotherapy who can provide a blood sample immediately before starting subsequent therapy.\n* Age ≥ 19 years at the time of enrollment.\n* Willingness to provide a blood sample for ctDNA analysis.\n\nExclusion Criteria:\n\n* Patients who refuse to provide blood samples for ctDNA testing.\n* Patients unable to provide written informed consent.\n* Patients concurrently enrolled in a similar study within the same institution. Prior screening will be performed to prevent duplicate enrollment.",{"count":136,"type":21},200,"Biliary tract cancer (BTC) is a rare and heterogeneous disease with high incidence and mortality in Korea. Molecular profiling has enabled the identification of actionable alterations such as Isocitrate Dehydrogenase 1 (IDH1) mutations, FGFR2 fusions, ERBB2 amplifications, and dMMR\u002FMSI-H status. However, the utility of tumor tissue-based next-generation sequencing (NGS) is often limited by difficulties in obtaining adequate tissue samples and the lack of in-house sequencing capacity across many hospitals.\n\nCirculating tumor DNA (ctDNA) analysis offers a minimally invasive alternative that can provide rapid and reliable genomic profiling. In a previous study, ctDNA testing showed high concordance with tissue-based genomic profiling for clinically significant alterations, particularly IDH1 mutations, and identified additional mutations not detected in tumor tissue. These findings suggest that ctDNA may expand access to targeted therapies such as ivosidenib .\n\nThis multicenter, prospective, observational epidemiology study, organized by the Korean Cancer Study Group (KCSG) Biliary Tract Cancer Subcommittee, will evaluate the clinical utility of ctDNA-based genomic profiling in patients with advanced BTC. The study will assess concordance between ctDNA and tumor tissue sequencing, describe the prevalence of actionable alterations, and explore the impact of ctDNA testing on treatment decisions and clinical outcomes. By leveraging a nationwide network of BTC specialists, this study seeks to validate ctDNA as a feasible and scalable tool for precision oncology, supporting timely and personalized therapy for patients with BTC.",[113],[113,115,116,117,119,118],{"date":122,"type":37},{"date":124,"type":37},{"date":143,"type":21},"2027-01-31",{"name":43,"class":44},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":152,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":45},"100565890","investigation-of-predictive-biomarkers-in-patients-with-advanced-btc-treated-with-lenvatinib-plus-pembrolizumab-100565890","NCT06648057","Investigation of Predictive Biomarkers in Patients With Advanced BTC Treated With Lenvatinib Plus Pembrolizumab","Investigation of Predictive Biomarkers in Patients With Advanced Biliary Tract Cancer Treated With Lenvatinib Plus Pembrolizumab","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed advanced biliary tract cancer.\n* Patients scheduled to receive Lenvatinib + Pembrolizumab for the treatment of advanced biliary tract cancer.\n* ECOG performance status of 0-2.\n* Patients aged 20 years or older at the time of treatment initiation.\n* Patients who understand and consent to participate in this study, and agree to provide samples obtained during the examination process.\n\nExclusion Criteria:\n\n* Patients who do not consent to participate in the study or withdraw their consent.","20 Years",{"count":109,"type":21},"The goal of this observational study is to evaluate the clinical efficacy and safety of lenvatinib plus pembrolizumab combination therapy in patients with advanced biliary tract cancer (BTC). This study aims to identify potential biomarkers that may predict treatment response by analyzing genetic data from blood and tissue samples. The study will focus on real-world clinical outcomes and the exploratory discovery of biomarkers associated with the efficacy of this treatment regimen.",[113,156],"Cholangiocarcinoma",[158,159,113,115,160],"Lenvatinib","Pembrolizumab","RNA sequencing",{"date":122,"type":37},{"date":163,"type":37},"2024-09-23",{"date":165,"type":21},"2026-12-31",{"name":43,"class":44},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":152,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100557820","phase-4-mact-mono-antiplatelet-and-colchicine-therapy-prospective-multicenter-study-100557820","NCT06543082","MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study","Clinical Outcomes of Colchicine Therapy Following Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study","MACT II","Inclusion Criteria:\n\n* Participants with positive troponin acute coronary syndrome who have undergone implantation of ultrathin bioresorbable polymer sirolimus-eluting stents (Orsiro; Biotronik AG).\n* Participants who have provided written informed consent.\n\nExclusion Criteria:\n\n* Under 19 years of age.\n* Stent treatment failure lesions (stent restenosis or thrombosis).\n* Cardiac arrest or cardiogenic shock.\n* Currently taking or requiring strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir\u002Fritonavir, indinavir, itraconazole, ketoconazole, lopinavir\u002Fritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir\u002Fritonavir) or P-glycoprotein inhibitors (cyclosporine, ranolazine).\n* Presence of any of the following concomitant conditions: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia, severe gastrointestinal diseases, or genetic disorders such as galactose intolerance.\n* Hypersensitivity to colchicine treatment.\n* Currently taking colchicine for another condition.\n* Requiring anticoagulant therapy.\n* Liver disease classified as Child-Pugh class B or C.\n* Renal disease with creatinine clearance \\\u003C30 mL\u002Fmin.\n* Pregnant, breastfeeding, or women of childbearing age.\n* Currently has a malignancy or has a history of malignancy within the past 5 years.\n* Life expectancy of less than 5 years.\n* Contraindication for ticagrelor use (history of intracranial hemorrhage, active pathological bleeding, or liver disease classified as Child-Pugh class B or C).\n* Patients receiving regular administration of systemic steroids, immunosuppressants, or biological agents (e.g., TNF-alpha inhibitors)\n* Patients with active infectious diseases","90 Years",{"count":177,"type":21},490,[179],"PHASE4","The previous Mono Antiplatelet and Colchicine Therapy (MACT) pilot study (NCT04949516) demonstrated that it was feasible to discontinue aspirin therapy and administer low-dose colchicine on the day after percutaneous coronary intervention (PCI) in addition to potent P2Y12 inhibitors in patients with acute coronary syndrome (ACS). However, the efficacy and safety of MACT have not yet been investigated. The goal of this clinical trial is to evaluate the clinical outcomes of ticagrelor P2Y12 inhibitor monotherapy combined with colchicine immediately after PCI in patients with ACS. The main questions it aims to answer are:\n\n* What is the frequency of the composite endpoint of cardiovascular death, nonfatal spontaneous myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding at 12 months post-intervention?\n* What is the frequency of stent thrombosis at 12 months post-intervention?\n\nFor pre-specified analyses, researchers will compare MACT to less than 1 month, 3-month, and 12-month dual antiplatelet therapy (individual patient data from the T-PASS \\[NCT03797651\\] and TICO \\[NCT02494895\\] trials) to determine if MACT is effective in treating ACS.\n\nParticipants will:\n\n* Take low-dose colchicine in addition to ticagrelor maintenance therapy, discontinuing aspirin the day after PCI.\n* Take a high-sensitivity C-reactive protein (hs-CRP) test 1 month after PCI.\n* Discontinue colchicine if the hs-CRP level is less than 2 mg\u002FL, or continue colchicine if it is not.\n* Visit the clinic for check-ups at 1, 3, 6, 9, and 12 months after PCI.",[182],"Acute Coronary Syndrome",[184],"Colchicine","2026-02-15",{"date":187,"type":37},"2026-02-18",{"date":189,"type":37},"2024-08-05",{"date":191,"type":21},"2028-12",{"name":43,"class":44},9,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":206,"conditions":207,"keywords":210,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":221,"locationsCount":45},"100603999","phase-1-a-study-to-evaluate-the-safety-of-a-stem-cell-based-gene-and-cell-therapy-in-patients-with-newly-diagnosed-glioblastoma-100603999","NCT07143812","A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma","Clinical Research of Suicide Gene Expressing Allogenic Bone Marrow Derived Mesenchymal Stem Cells(MSC11FCD) in Patients With Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* Patients aged 19 to 70\n* Patients diagnosed with newly diagnosed glioblastoma based on medical imaging after receiving standard therapy for glioblastoma\n* Patients whose expected survival period is at least 3 months\n* Patients who have not received any other types of immunotherapy\n* Patients who have been given a sufficient explanation of the purpose and details of the clinical trial and the characteristics of the investigational drug from an investigator and who signed the consent form or had a legal guardian or representative sign the consent form prior to the beginning of this clinical trial\n\nExclusion Criteria:\n\n* Patients with recurrent glioblastoma. Known Dihydropyrimidine Dehydrogenase (DPD) deficiency Contraindications to contrast-enhanced MRI (e.g., patients with pacemakers or other reasons preventing MRI scans according to the study schedule)\n* Patients who received Gliadel wafer implantation during surgery\n* Patients with severe dysfunction of major organs (liver, kidney, bone marrow, lung, heart) as determined by the investigator\n* Patients with concurrent malignancies other than glioblastoma or a history of malignancy within the past 5 years\n* Patients with uncontrolled hypotension or hypertension\n* Patients with serious infections as determined by the investigator, including sepsis, hepatitis A, B, or C\n* Patients with a Karnofsky Performance Scale (KPS) score \\\u003C 50\n* Patients with autoimmune diseases involving the central nervous system (e.g., multiple sclerosis, myasthenia gravis, acute disseminated encephalomyelitis)\n* Patients with a history of allergy to flucytosine (5-FC), its excipients, or 5-fluorouracil (5-FU)\n* Pregnant or breastfeeding women, patients planning to become pregnant during the study period, or those unwilling to use appropriate contraception\n* Participation in another clinical trial within 30 days prior to enrollment\n* Any condition that, in the opinion of the investigator, would make the patient unsuitable for study participation","70 Years",{"count":203,"type":21},10,[205],"PHASE1","This is a phase I clinical trial evaluating the safety, tolerability, and maximum tolerated dose of MSC11FCD, an investigational allogeneic bone marrow-derived mesenchymal stem cell therapy expressing a suicide gene, in patients with newly diagnosed glioblastoma. The investigational product is administered intratumorally following surgical resection. This study aims to explore whether MSC11FCD can provide a targeted, localized treatment option during the postsurgical period, potentially addressing residual tumor cells and reducing early recurrence.",[208,209],"Glioblastoma (GBM)","Newly Diagnosed Glioblastoma Multiforme",[211,212,213,214],"Glioblastoma","mesenchymal stem cell","gene therapy","suicide gene","2026-01-20",{"date":217,"type":37},"2026-01-22",{"date":219,"type":37},"2025-10-23",{"date":165,"type":21},{"name":43,"class":44},{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":232,"studyType":110,"phases":4,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":243,"locationsCount":45},"100584747","combination-therapy-of-gcnt-and-tislelizumab-in-advanced-biliary-tract-cancer-100584747","NCT06893380","Combination Therapy of GCNT and Tislelizumab in Advanced Biliary Tract Cancer","A Multicenter Phase 1b\u002F2 Trial Investigating the Efficacy and Toxicity of the Combination of Gemcitabine, Cisplatin, Nab-Paclitaxel, and Tislelizumab in Treatment Naïve Patients With Unresectable, Locally Advanced, or Metastatic BTC","GENTIS","Inclusion Criteria\n\n* Histologically confirmed biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer (excluding neuroendocrine tumors, sarcoma, mixed cholangiocarcinoma-HCC, and ampullary carcinoma).\n* Age ≥ 19 years at the time of signing informed consent.\n* Treatment-naïve for unresectable or metastatic BTC, or recurrence\u002Fmetastasis at least 6 months after curative surgery or adjuvant chemotherapy.\n* Measurable lesions per RECIST v1.1.\n* ECOG Performance Status (PS) of 0-1 within 14 days prior to the first dose.\n* Life expectancy of ≥ 3 months.\n* Adequate organ function (within 14 days prior to the first dose):\n\n  * Hematologic function: Hemoglobin (Hb) ≥ 9.0 g\u002FdL, Absolute neutrophil count (ANC) ≥ 1,500\u002FμL, Platelet count ≥ 100,000\u002FμL\n  * Renal function: Serum creatinine ≤ 1.5 × ULN or CrCl (Cockcroft-Gault) ≥ 45 mL\u002Fmin\n  * Hepatic function: AST and ALT ≤ 3.0 × ULN (≤ 5.0 × ULN for hepatic metastases), Total bilirubin ≤ 1.5 × ULN\n  * Coagulation: INR ≤ 1.5 or prothrombin time ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN\n* Reproductive status:\n\n  * Female participants must provide proof of non-childbearing status or a negative serum pregnancy test within 7 days before the first dose.\n  * Female subjects receiving cisplatin must agree to effective contraception for 14 months after the last dose; male subjects must agree for 11 months.\n  * Women of childbearing potential and non-sterilized men must use at least two effective contraceptive methods during the study and for 6 months after the last dose.\n* Cardiac function:\n\n  * Left ventricular ejection fraction (LVEF) ≥ 50% (by echocardiography or MUGA scan)\n  * No serious valvular disorders or arrhythmias\n  * Corrected QT interval ≤ 470 msec at screening\n* Willingness to provide tumor tissue samples by biopsy (endoscopic or excisional).\n\nExclusion Criteria\n\n* Prior treatment history:\n\n  * Prior systemic chemotherapy, biological therapy, immunotherapy, or hormone therapy for unresectable or metastatic BTC\n  * Prior adjuvant chemotherapy or radiation therapy within 6 months before recurrence\n* History of another malignancy within 5 years, except:\n\n  * Completely resected basal cell carcinoma, stage 1 squamous cell carcinoma, carcinoma in situ, or superficial bladder cancer\n* Unresolved toxicities from prior treatment that could affect study evaluation\n* Known hypersensitivity to any study drug (tislelizumab, gemcitabine, cisplatin, nab-paclitaxel)\n* Active or history of autoimmune disease, except:\n\n  * Hypothyroidism (on stable hormone therapy), vitiligo, or psoriasis not requiring treatment\n* History of interstitial lung disease, pulmonary fibrosis, or radiation pneumonitis\n* Active gastrointestinal disease:\n\n  * Active peptic ulcer, colitis, or diverticulitis Known central nervous system (CNS) metastasis\n* Uncontrolled tumor-related complications: Pericardial effusion, pleural effusion, or ascites requiring intervention, Uncontrolled tumor-related pain\n* Significant cardiovascular conditions:\n\n  * Myocardial infarction within 180 days before enrollment\n  * Uncontrolled angina within 180 days before enrollment\n  * NYHA Class III or IV congestive heart failure\n  * Persistent hypertension ≥ 150\u002F90 mmHg despite treatment\n  * Arrhythmias requiring medical intervention\n  * Thrombosis or vascular diseases requiring surgery\n* Uncontrolled diabetes mellitus\n* Active infections requiring systemic treatment within 14 days before the first dose\n* Recent treatment history:\n\n  * Systemic corticosteroids (except prophylactic or short-term use) or immunosuppressants within 28 days before the first dose\n  * Antitumor therapy (cytotoxic, targeted, or immunotherapy) within 28 days before the first dose\n  * Pleurodesis within 28 days before the first dose\n  * Major surgery under general anesthesia within 28 days before the first dose\n  * Local anesthesia or minor surgery within 14 days before the first dose\n  * Radiation therapy within 28 days before the first dose (bone metastasis radiation within 14 days is allowed)\n* Positive for:\n\n  * HIV-1 or HIV-2\n  * Active Hepatitis B or C (except HBV DNA \\\u003C500 IU\u002FmL with stable antiviral therapy)\n* Pregnant or breastfeeding women\n* Use of unapproved drugs within 28 days before enrollment\n* Cognitive impairment preventing informed consent\n* Severe neuropathy (Grade ≥ 2, CTCAE v5.0)\n* Hearing impairment\n* Inability or unwillingness to provide informed consent",{"count":231,"type":21},61,"2 Years","This is a multicenter Phase 1b\u002F2 clinical trial investigating the efficacy and safety of a combination regimen of Gemcitabine, Cisplatin, Nab-paclitaxel, and Tislelizumab in treatment-naïve patients with unresectable, locally advanced, or metastatic biliary tract cancers (BTC), including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.\n\nThe Phase 1b portion aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Nab-paclitaxel in combination with Gemcitabine, Cisplatin, and Tislelizumab. In the Phase 2 portion, the study will evaluate the Objective Response Rate (ORR) as the primary endpoint, with additional assessments of Overall Survival (OS), Progression-Free Survival (PFS), Disease Control Rate (DCR), and Quality of Life (QoL). Safety and tolerability will also be closely monitored.\n\nThis study seeks to leverage the stromal-disrupting effect of Nab-paclitaxel and the immune checkpoint blockade effect of Tislelizumab, combined with the established chemotherapy backbone of Gemcitabine and Cisplatin, to enhance treatment outcomes for BTC patients. The study will enroll patients across three medical centers in South Korea, including CHA Bundang Medical Center, Haeundae Paik Hospital, and Seoul National University Bundang Hospital.",[235,236],"Locally Advanced Biliary Tract Cancers","Metastatic Biliary Tract Cancers","2025-09-09",{"date":239,"type":37},"2025-09-15",{"date":241,"type":37},"2024-10-01",{"date":165,"type":21},{"name":43,"class":44},{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100591843","medipixel-xa-assisted-pci-in-coronary-artery-disease-100591843","NCT06985693","Medipixel XA-Assisted PCI in Coronary Artery Disease","Medipixel XA-Assisted Percutaneous Coronary Intervention in Coronary Artery Disease: A Prospective Multicenter Study","MAP I","Inclusion Criteria:\n\n* Silent ischemia, stable or unstable angina, or myocardial infarction\n* De novo coronary lesion eligible for DES implantation\n* Lesions analyzable by MPXA\n\nExclusion Criteria:\n\n* Comorbidity with a life expectancy \\\u003C12 months\n* Intolerant of antithrombotic therapy\n* Significant anemia, thrombocytopenia, or leucopenia\n* History of major hemorrhage (intracranial, gastrointestinal, and so on)\n* Chronic total occlusion lesion\n* Left main lesion\n* Severe calcification needing rotational atherectomy\n* Lesions not analyzable by MPXA",{"count":253,"type":21},830,[58],"This prospective, multicenter, single-arm, interventional study evaluates the effectiveness and safety of Medipixel XA-Assisted Percutaneous Coronary Intervention (MPXA-PCI) in patients with coronary artery disease (CAD). The study aims to assess procedural success rates and clinical outcomes associated with the novel MPXA-assisted PCI strategy in a real-world clinical setting.\n\nA total of 830 patients with de novo coronary lesions eligible for drug-eluting stent (DES) implantation will be enrolled. All participants will undergo MPXA-assisted lesion assessment to optimize balloon and stent selection. The primary outcome is target vessel failure (TVF) at 12 months, defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. Secondary outcomes include procedural success, angiographic results, and periprocedural complications.\n\nThis study will provide evidence regarding the clinical applicability and safety of artificial intelligence-assisted quantitative coronary analysis (AI-QCA) technology for optimizing PCI procedures.",[257,258],"Percutaneous Coronary Intervention (PCI)","Coronary Arterial Disease (CAD)",[260,261,262,263],"Artificial Intelligence","Quantitative Coronary Analysis","Medipixel","MPXA","2025-05-15",{"date":266,"type":37},"2025-05-22",{"date":264,"type":37},{"date":269,"type":21},"2028-05",{"name":43,"class":44},6,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":279,"minAge":152,"maxAge":201,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":299},"100471651","therapeutic-effect-of-surgical-debulking-of-metastatic-lymph-nodes-in-cervical-cancer-stage-iiicr-100471651","NCT05421650","Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr","Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr: A Phase III, Randomized Controlled Clinical Trial","1\\) Inclusion Criteria\n\n(1) Women aged ≥ 20 years and ≤ 70 years (2) Patients newly diagnosed with squamous cell carcinoma (SCC), adenocarcinoma, or adenosquamous carcinoma (3) Patients with a short-axis diameter of the pelvic LN or para-aortic LN under the renal vein of ≥ 1.5 cm or ≥ 2 LNs with a short-axis diameter ≥ 1 cm in CT or MRI (PET-CT can be used as an auxiliary tool) (4) Patients with CCRT planned as a treatment for cervical cancer (5) Patients whose competency is Eastern Cooperative Oncology Group performance score 0-1 (6) Patients who have signed the approved informed consent form for study participants (7) Patients in whom surgical debulking for LN metastasis was possible, as confirmed by radiological examination.\n\n2\\) Exclusion Criteria\n\n(1) Patients who have been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years (2) Patients who are pregnant or plans to conceive during the clinical study period (3) Patients with any active infectious disease or incurable severe inflammation (4) Patients who cannot undergo surgery due to internal or surgical disease (5) Patients who cannot receive chemotherapy due to internal or surgical disease (6) Patients with a history of pelvic RT (7) Patients with a history of subtotal hysterectomy (8) Patients with remote metastasis other than a pelvic or para-aortic LN (e.g., lung, subclavian, and inguinal LNs)","FEMALE",{"count":281,"type":21},240,[58],"This study is a prospective, multicenter and randomized clinical trial (DEBULK trial) to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) in cervical cancer stage IIICr.",[285],"Cervical Cancer",[287,288,289,290],"Cervical cancer IIICr","Bulky or multiple lymph nodes","Surgical debulking of lymph nodes","Concurrent chemoradiation therapy","2025-04-05",{"date":293,"type":37},"2025-04-09",{"date":295,"type":37},"2022-08-01",{"date":297,"type":21},"2030-12-31",{"name":43,"class":44},26,{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":312,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":45},"100578726","phase-4-the-analysis-of-efficacy-factors-for-autologous-platelet-rich-plasma-therapy-in-the-treatment-of-elbow-tendinopathy-100578726","NCT06815042","The Analysis of Efficacy Factors for Autologous Platelet-Rich Plasma Therapy in the Treatment of Elbow Tendinopathy","Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Diagnosed with elbow tendinopathy\n* Persistent pain despite receiving conservative treatment\n\nExclusion Criteria:\n\n* Individuals with systemic infection at the time of study participation\n* Patients with rheumatic diseases or inflammatory disorders\n* Individuals with unstable systemic conditions affecting the cardiovascular, gastrointestinal, respiratory, or endocrine systems\n* Any other cases deemed inappropriate for study participation by the investigator",{"count":307,"type":21},30,[179],"To identify key factors influencing the effectiveness of platelet-rich plasma (PRP) therapy in treating elbow tendinopathy, a common degenerative condition.",[311],"Elbow Tendinopathy",[313,314,315,316],"Platelet Rich Plasma","Protein Array Analysis","Growth factor","Patient-Rated Tennis Elbow Evaluation","2025-02-03",{"date":319,"type":37},"2025-02-07",{"date":321,"type":21},"2025-02",{"date":323,"type":21},"2025-12",{"name":43,"class":44},""]