[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625565":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":56,"locations":66,"responsibleParty":103,"collaborators":31,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":31,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":31,"enrollmentInfo":114,"targetDuration":31,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":31,"overallStatus":123,"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",[67,87],{"facility":68,"status":31,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Peking University First Hospital","Beijing","Beijing Municipality","100034","China","CN",{"type":75,"coordinates":76},"Point",[77,78],116.39723,39.9075,{"lat":78,"lon":77},[81,85],{"name":82,"role":59,"phone":83,"phoneExt":31,"email":84},"Zhisong He","+86-010-83572600","wyj7074@sohu.com",{"name":82,"role":86,"phone":31,"phoneExt":31,"email":31},"PRINCIPAL_INVESTIGATOR",{"facility":88,"status":31,"city":89,"state":90,"zip":91,"country":72,"countryCode":73,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Renji Hospital Affiliated to Shanghai Jiao Tong University School","Shanghai","Shanghai Municipality","200120",{"type":75,"coordinates":93},[94,95],121.45806,31.22222,{"lat":95,"lon":94},[98,102],{"name":99,"role":59,"phone":100,"phoneExt":31,"email":101},"Wei Xue","+86-021-58752345","uroxuewei@163.com",{"name":99,"role":86,"phone":31,"phoneExt":31,"email":31},{"type":104,"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":115,"type":116},236,"ESTIMATED","INTERVENTIONAL",[119],"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).",[122],"NMIBC","NOT_YET_RECRUITING","2026-05-29",{"date":126,"type":127},"2026-06-02","ACTUAL",{"date":129,"type":116},"2026-06",{"date":131,"type":116},"2030-06",{"name":5,"class":6},2]