[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643237":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":21,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":21,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":21,"enrollmentInfo":62,"targetDuration":21,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":21,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Shanxi Province Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Disitamab Vedotin Plus Intravesical Mitomycin C","EXPERIMENTAL","Participants will receive intravenous disitamab vedotin in combination with intravesical mitomycin C according to the protocol-defined treatment schedule.",[13,14],"Drug: Disitamab Vedotin","Drug: Mitomycin C (MMC)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Disitamab Vedotin","Disitamab Vedotin injection: 2.0 mg\u002Fkg, every two weeks, treatment lasts for 8 to 12 cycles",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Mitomycin C (MMC)","Mitomycin bladder intravesical instillation: 40mg per dose. Instill immediately after surgery, then once a week thereafter. The induction chemotherapy instillation lasts for 8 times. Subsequently, it is instilled once a month for a total of 10 months for maintenance chemotherapy.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Xuebing Han","CONTACT","86+17861282270","hanxuebing808@126.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Shanxi Provincial Cancer Hospital","RECRUITING","Taiyuan","Shanxi","030000","China","CN",{"type":42,"coordinates":43},"Point",[44,45],112.56028,37.86944,{"lat":45,"lon":44},[48],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","hanxuebin","Director of Urology Department","100643237","phase-2-disitamab-vedotin-plus-intravesical-mitomycin-c-in-her2-expressing-intermediate--to-high-risk-non-muscle-invasive-bladder-cancer-100643237",false,"NCT07646145","Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer","Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Medium-high Risk Non-Muscle-Invasive Bladder Cancer: A Phase II Clinical Trial","Inclusion Criteria:\n\n* Voluntary participation, signing a written informed consent form;\n* The age on the date of signing the informed consent form should be no less than 18 years old, regardless of gender;\n* The subjects have completed the standard TURBT procedure before signing the informed consent form, and no obvious residual tumor lesions were found in the surgical field;\n* The postoperative pathology clearly diagnosed as non-muscle-invasive bladder cancer, and the main tissue component was more than 50% urothelial carcinoma (transitional cell carcinoma);\n* The subjects were classified into the intermediate-risk or high-risk group according to the risk classification for NMIBC;\n* Tumor tissue samples for TURBT must be provided, along with the required relevant pathological reports. Fresh surgical tissues or pathological slides can be sent for examination as well;\n* The patients were intolerant to BCG or did not accept the BCG infusion treatment plan;\n* Before treatment, HER2 detection was conducted on the resection specimens in the laboratory: The IHC results confirmed HER2 expression (defined as: IHC 1+, 2+ or 3+);\n* Clinical non-metastatic bladder cancer (N0, M0) was determined by abdominal computed tomography (CT).\n\nExclusion Criteria:\n\n* History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;\n* Imaging results within 3 months before treatment indicated lymph node or other site\u002Forgan metastasis;\n* Imaging results within 3 months before treatment indicated the presence of other urinary system tumors;\n* Received other systemic anti-cancer treatments within 3 weeks before treatment, including chemotherapy, biological therapy, immunotherapy, targeted therapy, endocrine therapy, and\u002For investigational drug therapy;\n* Received bladder radiotherapy for urothelial carcinoma before treatment;\n* Known to have anaphylaxis or delayed allergic reaction to certain components of vedacitinib or similar drugs;\n* Within the 3 days prior to the first infusion, the following conditions had not yet been alleviated to CTCAE grade 1:Uncontrolled acute or chronic infections, such as pneumonia, biliary tract infections;Hepatitis B and Hepatitis C infections; dyspnea;Acute or chronic kidney injury; nephrotic syndrome; bladder perforation; urinary tract obstruction;\n* NYHA rating of 3 or 4;\n* Symptoms and signs related to cardiovascular diseases: including myocardial infarction, congestive heart failure, arrhythmia, etc.;\n* Known cerebrovascular accidents;\n* History of autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, hemolytic anemia, rheumatoid arthritis, etc.);\n* Known positive HIV serology, Hepatitis C infection and\u002For Hepatitis B (HepBsAg or core antibody positive and responding after antiviral treatment for Hepatitis B, except for these patients: these patients are allowed to participate in this study; Note: Patients with negative HepBsAg at screening)","ALL","18 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression. The goal is to provide a new treatment option for NMIBC patients, reduce the risk of tumor recurrence, decrease the proportion of radical bladder surgery, and improve the quality of life of patients.",[70],"Non-Muscle-Invasive Bladder Cancer (NMIBC)","2026-06-09",{"date":73,"type":74},"2026-06-12","ACTUAL",{"date":76,"type":74},"2024-04-01",{"date":78,"type":64},"2027-04",{"name":5,"class":6},1]