Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630871
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression2-3 Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicenter Single-Arm Phase Ⅱ Exploratory Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression2-3 Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective multicenter single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment of high-risk very high-risk NMIBC with HER2 2-3
Detailed Description:
The specific implementation process of trial
Patients diagnosed with high-risk and very high-risk NMIBC based on medical history clinical presentation imaging examinations such as MRI with plain and enhanced scanning and transurethral resection for tissue pathological biopsy are included in the case screening process After excluding surgical contraindications TURBt is performed postoperative tissue pathological examination confirms NMIBC and patients with immunohistochemical results of HER2 as 3 or 2 enter further screening Referring to the AUA guidelines high-risk and very high-risk NMIBC are included in subsequent analysis where those who meet the inclusion criteria of this study excluding the exclusion criteria and who have recovered well after the initial TURBt and are assessed to be able to complete a second TURBt within six weeks are considered as the final candidates for enrollment
Eligible patients for single-arm enrollment N40 will receive Tislelizumab 200mg Disitamab Vedotin 120mg for weight 60Kg or 20mgKg for weight 60Kg the day after the initial TURBt to be repeated every 3 weeks Q3W Patients are also scheduled to undergo a second TURBt within 6 weeks and after the surgery they will continue with three more courses of Tislelizumab Disitamab Vedotin Q3W until the end of the 3-year follow-up period The primary endpoint for evaluation in this study phase is the 1-year event-free survival EFS with secondary endpoints including 3-year EFS 2-year bladder intact disease-free survival BIDFS time to total cystectomy overall survival OS quality of life QLQ-C30 and adverse events
Patients diagnosed with high-risk and very high-risk NMIBC based on medical history clinical presentation imaging examinations such as MRI with plain and enhanced scanning and transurethral resection for tissue pathological biopsy are included in the case screening process After excluding surgical contraindications TURBt is performed postoperative tissue pathological examination confirms NMIBC and patients with immunohistochemical results of HER2 as 3 or 2 enter further screening Referring to the AUA guidelines high-risk and very high-risk NMIBC are included in subsequent analysis where those who meet the inclusion criteria of this study excluding the exclusion criteria and who have recovered well after the initial TURBt and are assessed to be able to complete a second TURBt within six weeks are considered as the final candidates for enrollment
Eligible patients for single-arm enrollment N40 will receive Tislelizumab 200mg Disitamab Vedotin 120mg for weight 60Kg or 20mgKg for weight 60Kg the day after the initial TURBt to be repeated every 3 weeks Q3W Patients are also scheduled to undergo a second TURBt within 6 weeks and after the surgery they will continue with three more courses of Tislelizumab Disitamab Vedotin Q3W until the end of the 3-year follow-up period The primary endpoint for evaluation in this study phase is the 1-year event-free survival EFS with secondary endpoints including 3-year EFS 2-year bladder intact disease-free survival BIDFS time to total cystectomy overall survival OS quality of life QLQ-C30 and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None