[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625565":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":56,"locations":66,"responsibleParty":104,"collaborators":31,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":31,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":31,"enrollmentInfo":115,"targetDuration":31,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":31,"overallStatus":69,"whyStopped":31,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-1501 + BCG Group","EXPERIMENTAL","SHR-1501, Bacillus Calmette Guerin (BCG).",[13,14],"Drug: SHR-1501 for Injection","Drug: BCG for Injection",{"label":16,"type":17,"description":18,"interventionNames":19},"Investigator-selected Chemotherapy Group","ACTIVE_COMPARATOR","Epirubicin or Pirarubicin or Gemcitabine or Hydroxycamptothecin or Mitomycin.",[20,21,22,23,24],"Drug: Epirubicin Hydrochloride for Injection","Drug: Pirarubicin Hydrochloride for Injection","Drug: Gemcitabine Hydrochloride for Injection","Drug: Hydroxycamptothecin for Injection","Drug: Mitomycin for Injection",[26,32,36,40,44,48,52],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","SHR-1501 for Injection","SHR-1501 for injection.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"BCG for Injection","Bacillus calmette guerin (BCG) for injection.",[9],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Epirubicin Hydrochloride for Injection","Epirubicin hydrochloride for injection.",[16],{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":31},"Pirarubicin Hydrochloride for Injection","Pirarubicin hydrochloride for injection.",[16],{"type":27,"name":45,"description":46,"armGroupLabels":47,"otherNames":31},"Gemcitabine Hydrochloride for Injection","Gemcitabine hydrochloride for injection.",[16],{"type":27,"name":49,"description":50,"armGroupLabels":51,"otherNames":31},"Hydroxycamptothecin for Injection","Hydroxycamptothecin for injection.",[16],{"type":27,"name":53,"description":54,"armGroupLabels":55,"otherNames":31},"Mitomycin for Injection","Mitomycin for injection.",[16],[57,62],{"name":58,"role":59,"phone":60,"phoneExt":31,"email":61},"Wenliang Wang","CONTACT","+86-0518-82342973","wenliang.wang@hengrui.com",{"name":63,"role":59,"phone":64,"phoneExt":31,"email":65},"Qi Zhang","+86-021-60453139","qi.zhang@hengrui.com",[67,88],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Peking University First Hospital","RECRUITING","Beijing","Beijing Municipality","100034","China","CN",{"type":76,"coordinates":77},"Point",[78,79],116.39723,39.9075,{"lat":79,"lon":78},[82,86],{"name":83,"role":59,"phone":84,"phoneExt":31,"email":85},"Zhisong He","+86-010-83572600","wyj7074@sohu.com",{"name":83,"role":87,"phone":31,"phoneExt":31,"email":31},"PRINCIPAL_INVESTIGATOR",{"facility":89,"status":69,"city":90,"state":91,"zip":92,"country":73,"countryCode":74,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Renji Hospital Affiliated to Shanghai Jiao Tong University School","Shanghai","Shanghai Municipality","200120",{"type":76,"coordinates":94},[95,96],121.45806,31.22222,{"lat":96,"lon":95},[99,103],{"name":100,"role":59,"phone":101,"phoneExt":31,"email":102},"Wei Xue","+86-021-58752345","uroxuewei@163.com",{"name":100,"role":87,"phone":31,"phoneExt":31,"email":31},{"type":105,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100625565","phase-3-a-study-of-intravesical-shr-1501-combination-with-bcg-versus-investigator-selected-chemotherapy-in-subjects-with-bcg-unresponsive-nmibc-100625565",false,"NCT07424287","A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC","A Multicenter, Randomized, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1)","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-risk non-muscle invasive bladder cancer (high-grade Ta and\u002For any T1, no carcinoma in situ); BCG-unresponsive;\n4. 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;\n5. Not suitable for or unwilling to undergo radical cystectomy;\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 the following treatments and have not experienced disease recurrence or progression before enrolment: a) Intravesical infusion of cytotoxic chemotherapy or other drugs (such as oncolytic viruses), etc; b) Immune checkpoint inhibitors; c) Other investigatory drugs for the treatment of NMIBC;\n4. Those who have previously received immunostimulant therapy;\n5. 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;\n6. Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization.","ALL","18 Years",{"count":116,"type":117},236,"ESTIMATED","INTERVENTIONAL",[120],"PHASE3","This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive papillary-only non-muscle-invasive bladder cancer (NMIBC).",[123],"NMIBC","2026-07-16",{"date":126,"type":127},"2026-07-20","ACTUAL",{"date":129,"type":127},"2026-07-13",{"date":131,"type":117},"2030-06",{"name":5,"class":6},2]