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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. - Trial NCT06364904

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.

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NCT06364904
Phase 3
Not yet recruiting
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Trial Details
ClinicalTrials.gov • NCT06364904
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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.

Study Focus

Bladder Cancer

Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib

Interventional

drug

Sponsor & Location

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou,Guangzhou,Guangzhou,Guangzhou,Guangzhou,Wuhan,Changsha,Changsha, China

Timeline & Enrollment

Phase 3

Apr 15, 2024

Apr 15, 2029

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 bladder
Malignant neoplasm: Bladder, unspecified
Malignant neoplasm: Dome of bladder
Malignant neoplasm: Overlapping lesion of bladder
Malignant neoplasm: Lateral wall of bladder

Data Source

ClinicalTrials.gov

NCT06364904

Non-Device Trial