protocolSection identificationModule nctId: NCT06364904, orgStudyIdInfo id: SYSKY-2024-123-02, briefTitle: An Phase III Study, Multicenter，Randomized Controlled Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2029-04-15, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib, interventions name: Tislelizumab, Cisplatin, Gemcitabine, outcomesModule primaryOutcomes measure: Progression-Free Survival(PFS), primaryOutcomes measure: Incidence of Grade 3/4 Neutropenia, secondaryOutcomes measure: ORR, secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: Safety and AE, secondaryOutcomes measure: Disease Control Rate(DCR), secondaryOutcomes measure: During Of Response(DOR), secondaryOutcomes measure: Biomarker Endpoint Analyses, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, city: Guangzhou, state: Guangdong, country: China, contacts name: Fan Wu, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun Yat-sen Memorial Hospital, city: Guangzhou, state: Guangdong, country: China, contacts name: Wenlong Zhong, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Sun Yat-sen University, city: Guangzhou, state: Guangdong, country: China, contacts name: Junxin Chen, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Affiliated Hospital of Sun Yat-sen University, city: Guangzhou, state: Guangdong, country: China, contacts name: Yun Luo, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Zhujiang Hospital of Southern Medical University, city: Guangzhou, state: Guangdong, country: China, contacts name: Ebai Xu, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, country: China, contacts name: Zheng Liu, Ph.D, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, country: China, contacts name: Yu Xie, Ph.D, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Xiangya Hospital, Central South University, city: Changsha, state: Hunan, country: China, contacts name: Xiongbing Zu, Ph.D, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False