[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649039":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":25,"locations":35,"responsibleParty":66,"collaborators":11,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":11,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":11,"overallStatus":87,"whyStopped":11,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-1501+BCG","EXPERIMENTAL",null,[13],"Drug: SHR-1501+BCG",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo +BCG","PLACEBO_COMPARATOR",[18],"Drug: Placebo +BCG",[20,23],{"type":21,"name":9,"description":9,"armGroupLabels":22,"otherNames":11},"DRUG",[9],{"type":21,"name":15,"description":15,"armGroupLabels":24,"otherNames":11},[15],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Wenliang Wang","CONTACT","0518-82342973","wenliang.wang@hengrui.com",{"name":32,"role":28,"phone":33,"phoneExt":11,"email":34},"Qi Zhang","021-60453139","qi.zhang@hengrui.com",[36,53],{"facility":37,"status":11,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The First Medical Center of the Chinese People's Liberation Army General Hospital","Beijing","Beijing Municipality","100036","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":51,"role":52,"phone":11,"phoneExt":11,"email":11},"Xu Zhang","PRINCIPAL_INVESTIGATOR",{"facility":54,"status":11,"city":55,"state":56,"zip":57,"country":41,"countryCode":42,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060",{"type":44,"coordinates":59},[60,61],113.25,23.11667,{"lat":61,"lon":60},[64],{"name":65,"role":52,"phone":11,"phoneExt":11,"email":11},"Kai Yao",{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100649039","phase-3-a-study-of-shr-1501-combination-with-bcg-versus-placebo-combined-with-bcg-in-subjects-with-papillary-only-nmibc-100649039",false,"NCT07726992","A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC","A Multicenter, Randomized, Double-blind Phase III Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Placebo Combined With BCG In Patients With High-risk BCG-naive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC)","NiBladder 2","Inclusion Criteria:\n\n1. Aged at least 18 years, gender is not limited;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;\n3. Histologic confirmation of high-riskpapillary-only non-muscle invasive bladder cancer (high-grade Ta and\u002For any T1, no carcinoma in situ);\n4. No previous BCG therapy;\n5. Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue;\n6. Sufficient hematology and organ function;\n\nExclusion Criteria:\n\n1. Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+).\n2. Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization;\n3. Those who have previously received immunostimulant therapy or immune checkpoint inhibitors;\n4. Those who have previously received intravesical instillation of cytotoxic chemotherapy and have not experienced disease recurrence or progression before enrolment as assessed by investigator;\n5. Those who plan to undergo radical (partial) cystectomy during the study;\n6. Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;\n7. Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization;","ALL","18 Years",{"count":79,"type":80},750,"ESTIMATED","INTERVENTIONAL",[83],"PHASE3","This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)",[86],"Papillary-Only Non-muscle-invasive Bladder Cancer","NOT_YET_RECRUITING","2026-07-21",{"date":90,"type":91},"2026-07-27","ACTUAL",{"date":93,"type":80},"2026-07",{"date":95,"type":80},"2030-08",{"name":5,"class":6},2]