Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06241755
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2024-01-28
Brief Title:
Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of MediumHigh-risk Non-muscle Invasive Bladder Cancer NMIBC
Sponsor:
Chengdu CoenBiotech Co Ltd
Organization:
Chengdu CoenBiotech Co Ltd
Study Overview
Official Title:
Phase III Multi-center Randomized Double-blind and Positive-controlled Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of MediumHigh-risk Non-muscle Invasive Bladder Cancer NMIBC
Status:
RECRUITING
Status Verified Date:
2024-01
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:
A phase III multi-center randomized double-blind and positive-controlled clinical trial for evaluating the efficacy and safety of BCG for Therapeutic UseBCG in the prevention of postoperative recurrence of mediumhigh-risk non-muscle invasive bladder cancer NMIBC
Detailed Description:
Instillation of BCG for Therapeutic UseBCG into the urinary bladder intravesical administration improves rates of tumor recurrence and progression after adequate transurethral resection of bladder TURBt of moderate to high risk non-muscle-invasive bladder cancer NMIBC
To determine the efficacy and safety of BCG as an adjuvant therapy method in patients with NMIBC we conduct a randomized double-blinded positive controlled phase 3 clinical trial The target population is adults with moderate to high risk NMIBC Ta T1 or tis suitable for intravesical BCG treatment Key eligibility criteria include prior transurethral resection of all visible tumor adequate organ function and ECOG performance status 0-2 412 Subjects will be administrated with 120mg Intravesical BCG The treatment includes Induction perfusion period weekly x 6 followed by maintenance perfusion period Q2W x 3 times then once monthly totaled with 19 times BCG perfusion and lasting until 1 year after surgery The primary endpoint is 1-year recurrence-free survival rate
To determine the efficacy and safety of BCG as an adjuvant therapy method in patients with NMIBC we conduct a randomized double-blinded positive controlled phase 3 clinical trial The target population is adults with moderate to high risk NMIBC Ta T1 or tis suitable for intravesical BCG treatment Key eligibility criteria include prior transurethral resection of all visible tumor adequate organ function and ECOG performance status 0-2 412 Subjects will be administrated with 120mg Intravesical BCG The treatment includes Induction perfusion period weekly x 6 followed by maintenance perfusion period Q2W x 3 times then once monthly totaled with 19 times BCG perfusion and lasting until 1 year after surgery The primary endpoint is 1-year recurrence-free survival rate
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