[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"papillary-only-non-muscle-invasive-bladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:papillary-only-non-muscle-invasive-bladder-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},750,"ESTIMATED","INTERVENTIONAL",[24],"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)",[27],"Papillary-Only Non-muscle-invasive Bladder Cancer","NOT_YET_RECRUITING","2026-07-21",{"date":31,"type":32},"2026-07-27","ACTUAL",{"date":34,"type":21},"2026-07",{"date":36,"type":21},"2030-08",{"name":38,"class":39},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","INDUSTRY",2]