protocolSection identificationModule nctId: NCT06364956, orgStudyIdInfo id: SYSKY-2024-124-02, briefTitle: Phase Ib/II Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-06, 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: In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor Palbociclib in combination with the Tislelizumab in platinum-refractory cT2-4aN0M0 bladder urothelial carcinoma, a phase Ib/II study was conducted.This study will adopt a 3+3 design and include two predefined dose groups of palbociclib: 100mg QD, 125mg QD. Initially, Tislelizumab, 200 mg administered by intravenous infusion on Day 1 of each 21-day will be administered in combination. The trial will use the first cycle (28 days) as the observation period for tolerability, observing and evaluating the occurrence of DLTs after medication and determining the maximum tolerated dose/maximum administered dose (MTD/MAD) and recommended phase 2 dose (RP2D) of the combination therapy (30 patients) .This study provide further evidence for improving the efficacy of neoadjuvant treatment forplatinum-refractory cT2-4aN0M0 bladder urothelial carcinoma and to offer new options for precision treatment of bladder cancer., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab combined with two predefined dose groups of palbociclib, interventions name: RP2D dose Of Tislelizumab combined with palbociclib was selected for phase II clinical trial., outcomesModule primaryOutcomes measure: Phase I: the safety dose of the combination of Tislelizumab and palbociclib, primaryOutcomes measure: Phase II: Pathological complete response rate(pCR), secondaryOutcomes measure: Pathological Downstaging(pDS), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: Safety and AE, otherOutcomes measure: Biomarker Endpoint Analyses, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, 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, status: RECRUITING, 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, status: RECRUITING, 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, status: RECRUITING, 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, status: RECRUITING, 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, status: RECRUITING, 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, status: RECRUITING, 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, status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Xiongbing Zu, Ph.D, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False