[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100428632":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":53,"collaborators":30,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":30,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":30,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":38,"whyStopped":30,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Zhujiang Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Toripalimab+Gemcitabine\u002FCisplantin（GC）","EXPERIMENTAL","Subjects receive gemcitabine\u002Fcisplatin every 21 days, repeated for 4 cycles. . Toripalimab is given every 21 days for 4 doses starting C1D1. Subjects will then have consolidative surgery to remove their primary tumor within 6 weeks after their last dose of neoadjuvant therapy.",[13],"Drug: Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin","4 cycle neoadjuvant therapy and radical cystectomy",[9],[21],"Toripalimab",[23],{"name":24,"affiliation":5,"role":25},"Abai Xu, doctor","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+86 18665626790",null,"lc96xab@163.com",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Peng Xu Xu, doctor","+86 18665073650","yihuixp88@163.com",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Guangzhou","Guangdong","510282","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51],{"name":52,"role":28,"phone":30,"phoneExt":30,"email":30},"Peng Xu",{"type":25,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Abai Xu","Vice Director","100428632","phase-2-neoadjuvant-toripalimab-in-combination-with-gemcitabine-and-cisplatin-therapy-in-local-advanced-bladder-cancer-subjects-100428632",false,"NCT04861584","Neoadjuvant Toripalimab in Combination with Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects","Phase II Study of Neoadjuvant Toripalimab with Gemcitabine-Cisplatin in Subjects with T2-4aN0M0 Bladder Cancer: GZZJU-2021NB","Inclusion Criteria:\n\n* Patients between 18 and 75 years old on day of signing informed consent, regardless of gender;\n* ECOG score 0-1 points, expected survival time\\> 6 months;\n* Pathologically confirmed locally advanced bladder urothelial carcinoma (cT2-T4a, N≤1, M0, tumor staging according to American Joint Committee on Cancer (AJCC), 2017, eighth edition);\n* Appropriate and plan for radical cystectomy;\n* According to the RECIST1.1 standard, there is at least one measurable lesion (spiral CT scan ≥10mm);\n* Since the diagnosis of locally advanced bladder urothelial carcinoma, patient has not received anti-tumor system treatment;\n* The main organ functions are normal, and the following requirements must be met within 2 weeks before the first study treatment:\n* Routine blood examination must meet: WBC≥4.0×109\u002FL; PLT≥90×109\u002FL; Hb≥90g\u002FL (patients can be infused with red blood cells to meet this standard);\n* Blood biochemical examination must meet: serum creatinine (Cr) ≤1.5 times the upper limit of normal (ULN) or endogenous creatinine clearance ≥60mL\u002Fmin; TBIL≤1.5×ULN; ALB≥30g\u002FL; ALT and AST≤ 3.0×ULN; TSH≤1.5×ULN.\n* Female patients with fertility must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they voluntarily adopt appropriate methods of contraception during the observation period and within 8 weeks after the last administration;\n* Agree to provide diagnosis and treatment-related tumor tissue specimens for clinical research, and have the ability to follow the planned research visit until the clinical recurrence\u002Fprogress is clear.\n* Sign informed consent voluntarily.\n\nExclusion Criteria:\n\n* Have previously received anti-PD1\u002FPDL1\u002FCTLA-4 antibody treatment or systemic chemotherapy, bladder infusion chemotherapy is excluded;\n* Have received bladder bacille Calmette Guerin (BCG) infusion therapy within 4 weeks;\n* Have received radiotherapy of the bladder in the past;\n* Patients with any history of active autoimmune disease or autoimmune disease;\n* Complicated diseases that require the use of immunosuppressive drugs; concurrent diseases that require the use of immunosuppressive agents for systemic or locally absorbable corticosteroids. It is forbidden to use prednisone greater than 10 mg\u002Fday or the same dose in the 2 weeks before the use of the study drug;\n* Combined with other malignant tumors;\n* Have a history of allergy to other antibody drugs;\n* The history of human immunodeficiency virus (HIV) infection;\n* The subject has active infection, including active tuberculosis;\n* Combined with severe heart disease, or combined with New York Heart Association (NYHA) grade 3 or 4 cardiac insufficiency;\n* Kidney transplant patients;","ALL","18 Years","75 Years",{"count":67,"type":68},41,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","This is a pre-surgical study involving subjects with local advanced bladder cancer, who are candidates for neoadjuvant therapy. It is a single-arm phase II portion.",[74],"Urinary Bladder Cancer",[76,77,78],"bladder cancer","checkpoint inhibitor","neoadjuvant therapy","2024-11-30",{"date":81,"type":82},"2024-12-04","ACTUAL",{"date":84,"type":82},"2021-06-03",{"date":86,"type":68},"2027-04-03",{"name":5,"class":6},1]