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.

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

April 15, 2027

Study Completion Date

April 15, 2029

Conditions
Bladder Cancer
Interventions
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."

Trial Locations (8)

Unknown

Nanfang Hospital, Southern Medical University, Guangzhou

Sun Yat-sen Memorial Hospital, Guangzhou

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou

The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou

Zhujiang Hospital of Southern Medical University, Guangzhou

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

Hunan Cancer Hospital, Changsha

Xiangya Hospital, Central South University, Changsha

All Listed Sponsors
lead

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

OTHER