Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441110
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-14
Brief Title:
Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Sponsor:
Fujian Medical University Union Hospital
Organization:
Fujian Medical University Union Hospital
Study Overview
Official Title:
Multicentre Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With BCG Bladder Instillation in the Prevention of Postoperative Recurrence in Intermediate and High-risk Non-muscle Invasive Bladder Cancer
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:
Previous studies have reported the efficacy of Bacillus Calmette-Guérin BCG combined with other drugs for the treatment of bladder cancer However research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective Currently ongoing clinical trials have not discussed the effectiveness of PD-1PD-L1 inhibitors combined with BCG instillation in reducing postoperative recurrence in intermediate-risk NMIBC Therefore this study aims to explore the clinical efficacy and safety of tislelizumab combined with BCG in the treatment of intermediate and high-risk NMIBC For this purpose investigators have established strict screening criteria to include eligible patients in the study and have recruited suitable patients from multiple medical centersInvestigators have also developed a meticulous implementation process and follow-up considerations hoping to better verify the clinical efficacy and safety of the combined use of these two drugs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None