[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613054":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":52,"collaborators":21,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":21,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":21,"studyType":68,"phases":69,"briefSummary":72,"conditions":73,"keywords":21,"overallStatus":76,"whyStopped":21,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Entinostat plus chemotherapy","EXPERIMENTAL","The study was divided into two phases: chemotherapy phase and continuous treatment phase. During chemotherapy phase, patients receive 6 cycles of GC (gemcitabine and cisplatin) chemotherapy along with entinostat followed by efficacy evaluation. If stable disease is reached according to RECIST 1.1 criteria, patients may receive continuous entinostat treatment until disease progression or intolerable side effects.",[13,14],"Drug: Entinostat","Drug: Chemotherapy",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Entinostat","Take entinostat 5mg orally once weekly (at least 1 hour before meal and 2 hours after meal).",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Chemotherapy","Gisantinib and cisplatin chemotherapy for 6 cycles, 21 days per cycle. Gisantinib 1000mg\u002Fm2 is given intravenously on Day 1 and 8 for each cycle while cisplatin 70mg\u002Fm2 is given intravenously on Day2.",[9],[27],{"name":28,"affiliation":29,"role":30},"Hongqian Guo, PhD","Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Junlong Zhuang, PhD","CONTACT","15950451917","zhuangjl-2008@163.com",{"name":28,"role":34,"phone":21,"phoneExt":21,"email":21},[39],{"facility":40,"status":21,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":21},"Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University","Nanjing","Jiangsu","210008","China","CN",{"type":47,"coordinates":48},"Point",[49,50],118.77778,32.06167,{"lat":50,"lon":49},{"type":30,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Hongqian Guo","Chief physician","100613054","phase-1-entinostat--chemotherapy-for-locally-advanced-or-metastatic-bladder-cancer-100613054",false,"NCT07261592","Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer","Entinostat Combined With Chemotherapy as Second-line Therapy for Unresectable Locally Advanced or Metastatic Bladder Cancer: A Single-arm, Prospective Clinical Trial","Inclusion Criteria:\n\n* Histopathologic confirmed unresectable advanced or metastatic bladder cancer, except for those with squamous differentiation, glandular differentiation or both;\n* Failure of first-line treatment;\n* There is at least one measurable lesion according to RECIST 1.1;\n* Archived tumor tissue samples or tumor biopsies must be provided;\n* ECOG score of 0-1 an an estimated survival of at least 6 months;\n* Adequate organ function;\n* Patients voluntarily participated in this study, signed the informed consent form, and had good compliance;\n* Women with fertility must consent to contraception during the study and for 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n* Patients who received platinum-based chemotherapy after failure of first-line treatment;\n* Patients who received platinum-based chemotherapy withnin a 24 month before this trial;\n* Those who have received other anti-tumor treatment or participated in other clinical studies within 4 weeks before the start of the study, or have not recovered from the last toxicity (except grade 2 hair loss and grade 1 neurotoxicity);\n* Concomitant disease such as uncontrolled hypertension or diabetes, renal inadequacy, myocardial infarction, severe angina;\n* Female subjects who are pregnant, breastfeeding or planning to become pregnant during the study;\n* Patients with serious physical or mental illnesses.","ALL","18 Years","75 Years",{"count":66,"type":67},29,"ESTIMATED","INTERVENTIONAL",[70,71],"PHASE1","PHASE2","This single-center single-arm, open-label prospective clinical trial aimed to evaluate the efficacy and safety of entinostat combined with chemotherapy as second-line therapy for unresectable locally advanced or metastatic bladder cancer.",[74,75,18,23],"Bladder Cancer","Histone Deacetylase Inhibitor","NOT_YET_RECRUITING","2025-11-22",{"date":79,"type":80},"2025-12-03","ACTUAL",{"date":82,"type":67},"2025-12-01",{"date":84,"type":67},"2029-04-30",{"name":5,"class":6},1]