Clinical Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

May 15, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Bladder Cancer
Interventions
DRUG

Tislelizumab combined with two predefined dose groups of palbociclib

Tislelizumab, 200mg q3W, combined with two predefined dose groups of palbociclib: 100mg QD and 125mg QD, separately.

DRUG

RP2D dose Of Tislelizumab combined with palbociclib was selected for phase II clinical trial.

After the exploration of Tislelizumab, 200mg q3W combined with palbociclib, and the maximal tolerated dose (MTD) was determined, then RP2D dose of Tislelizumab combined with palbociclib was selected for phase II clinical trial.

Trial Locations (8)

Unknown

RECRUITING

Nanfang Hospital, Southern Medical University, Guangzhou

RECRUITING

Sun Yat-sen Memorial Hospital, Guangzhou

RECRUITING

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

RECRUITING

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

RECRUITING

Zhujiang Hospital of Southern Medical University, Guangzhou

RECRUITING

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

RECRUITING

Hunan Cancer Hospital, Changsha

RECRUITING

Xiangya Hospital, Central South University, Changsha

All Listed Sponsors
lead

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

OTHER