Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364956
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-06
Brief Title:
Phase IbII Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
A Phase IbII Prospective Study to Evaluate the Safety and Efficacy of the Combination of Neoadjuvant Palbociclib and Tislelizumab in Platinum-refractory cT2-4aN0M0 Bladder Urothelial Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In order to explore the safety and antitumor efficacy of different doses of CDK46 inhibitor Palbociclib in combination with the Tislelizumab in platinum-refractory cT2-4aN0M0 bladder urothelial carcinoma a phase IbII study was conducted
This study will adopt a 33 design and include two predefined dose groups of palbociclib 100mg QD 125mg QD Initially Tislelizumab 200 mg administered by intravenous infusion on Day 1 of each 21-day will be administered in combination The trial will use the first cycle 28 days as the observation period for tolerability observing and evaluating the occurrence of DLTs after medication and determining the maximum tolerated dosemaximum administered dose MTDMAD and recommended phase 2 dose RP2D of the combination therapy 30 patients
This study provide further evidence for improving the efficacy of neoadjuvant treatment forplatinum-refractory cT2-4aN0M0 bladder urothelial carcinoma and to offer new options for precision treatment of bladder cancer
This study will adopt a 33 design and include two predefined dose groups of palbociclib 100mg QD 125mg QD Initially Tislelizumab 200 mg administered by intravenous infusion on Day 1 of each 21-day will be administered in combination The trial will use the first cycle 28 days as the observation period for tolerability observing and evaluating the occurrence of DLTs after medication and determining the maximum tolerated dosemaximum administered dose MTDMAD and recommended phase 2 dose RP2D of the combination therapy 30 patients
This study provide further evidence for improving the efficacy of neoadjuvant treatment forplatinum-refractory cT2-4aN0M0 bladder urothelial carcinoma and to offer new options for precision treatment of bladder cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None