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.

NCT06364904 Phase 3 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	210
Start date	2025-10
Completion	2029-04-15

Conditions

• Bladder Cancer

Interventions

• Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib
• Tislelizumab, Cisplatin, Gemcitabine

Primary outcomes

• Percentage of Participants With Progression-Free Survival(PFS) — 24 months
  Progression free survival was determined from start date of treatment to date of progression for patients who progressed or date of death for patients who died without progressing. The observations of patients remaining alive and progression free were censored at the date of last disease evaluation. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
• Percentage of Participants With Incidence of Grade 3/4 Neutropenia — Within 28 days of initial dosing
  The proportion of participant with neutrophils with values \< 1\*10\^9/L during treatment.

Countries

China