NCT06364904

A Clinical 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.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib	Chemoimmunotherapy: 1. Tislelizumab: 200mg, 1x time at d1 each cycle 2. Gemcitabine: 1000mg/ m2, in d1, d8 each cycle 3. Cisplatin: 70 mg/m2, in d2 each cycle 4. Trilaciclib: 240mg/m2, d1, d2, d8 each cycle Tislelizumab maintenance therapy: after chemoimmunotherapy, 200mg, q3W.
DRUG	Tislelizumab, Cisplatin, Gemcitabine	Chemoimmunotherapy: 1. Tislelizumab: 200mg, 1x time at d1 each cycle 2. Gemcitabine: 1000mg/ m2, in d1, d8 each cycle 3. Cisplatin: 70 mg/m2, in d2 each cycle Tislelizumab maintenance therapy: after chemoimmunotherapy, 200mg, q3W.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-04-15
• Completion: 2029-04-15
• First posted: 2024-04-15
• Last updated: 2025-02-21

Locations

8 sites across 1 country: China

Regulatory

• FDA-regulated drug study