[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608920":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":60,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":26,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":94,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DV + BCG","EXPERIMENTAL","Disitamab Vedotin + BCG induction and maintenance",[13],"Drug: DV + BCG induction and maintenance",{"label":15,"type":16,"description":17,"interventionNames":18},"BCG","ACTIVE_COMPARATOR","BCG induction and maintenance",[19],"Drug: Active Comparator: BCG induction and maintenance",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Active Comparator: BCG induction and maintenance","Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer\n\nOther Names:\n\nBCG",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"DV + BCG induction and maintenance","Drug: Disitamab vedotin(RC48) •An antibody-drug conjugates (ADCs) targeting HER2, has been approved in China for chemotherapy-refractory advanced UC with HER2-expression.\n\nOther Names:\n\n• RC48, DV\n\nDrug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer\n\nOther Names:\n\nBCG",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Yi jun Shen, M.D.","CONTACT","862164175590","yijunshen@urocancer.org",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200230","China","CN",{"type":46,"coordinates":47},"Point",[48,49],121.45806,31.22222,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Dingwei Ye, Ph.D.","13817126663","dwyeli@163.com",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ding-Wei Ye","Director of Urology",[61,63,66,69],{"name":62,"class":6},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"name":64,"class":65},"Fujian Cancer Hospital","OTHER_GOV",{"name":67,"class":68},"Tenth People's Hospital of Tongji Univeristy","UNKNOWN",{"name":70,"class":65},"Ningbo Medical Center Lihuili Hospital","100608920","phase-3-dvbcg-in-her2-expressing-bcg-nave-high-risk-nmibc-100608920",false,"NCT07207824","DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC","A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined With Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients With HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer","HERO","Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Histologically confirmed high-risk, non-muscle-invasive urothelial carcinoma of the bladder (UCC) (with \\>50% urothelial carcinoma as the predominant histological component), defined by the presence of any of the following: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS).\n3. Complete resection of all Ta\u002FT1 papillary lesions (including patients with concomitant CIS). The most recent Transurethral Resection of Bladder Tumor (TURBT) must have been performed within 12 weeks prior to randomization. A second TURBT was required if indicated per current local applicable guidelines.\n4. HER2 expression (IHC 1+\u002F2+\u002F3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.\n5. Unwillingness or ineligibility to undergo radical cystectomy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.\n7. Signed informed consent form (ICF).\n\nExclusion Criteria\n\n1. Histologically confirmed evidence of muscle-invasive (T2 or higher), locally advanced, or metastatic urothelial carcinoma, or the presence of concurrent extravesical non-muscle-invasive urothelial carcinoma.\n2. Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.\n3. History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).\n4. Prior therapy with any other type of HER2-targeted inhibitor.\n5. Major surgery within 2 weeks prior to randomization.\n6. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.","ALL","18 Years",{"count":82,"type":83},182,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.",[89,90],"Bladder (Urothelial, Transitional Cell) Cancer","NMIBC",[90,92,93,15],"disitamab vedotin","HER2","NOT_YET_RECRUITING","2025-09-28",{"date":97,"type":98},"2025-10-06","ACTUAL",{"date":100,"type":83},"2025-12-01",{"date":102,"type":83},"2030-12-01",{"name":5,"class":6},1]