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NCT06364904Not yet recruiting

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.

A Multicenter, III Stage, Randomized Controlled Trail on the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib in Untreated Unresectable and Metastatic Urothelial Carcinoma.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Bladder Cancer
Drug/Device/Intervention
Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Location
Guangzhou,Guangzhou,Guangzhou,Guangzhou,Guangzhou,Wuhan,Changsha,Changsha, China
Timeline & enrollment
Phase
Phase 3
Start date
Apr 15, 2024
End date
Apr 15, 2029
Enrollment
210 participants
Primary outcome

Progression-Free Survival(PFS),Incidence of Grade 3/4 Neutropenia

Summary

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.

ICD-10 classifications
Malignant neoplasm of bladderMalignant neoplasm: Bladder, unspecifiedMalignant neoplasm: Dome of bladderMalignant neoplasm: Overlapping lesion of bladderMalignant neoplasm: Lateral wall of bladder
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06364904
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06364904 through Pure Global AI's free database. This Phase 3 trial is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University and is currently Not yet recruiting. The study focuses on Bladder Cancer. Target enrollment is 210 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.