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Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer

Bladder Cancer Clinical Trial

Official title:
Efficacy and Safety of Pseudomonas Aeruginosa Followed by Postoperative Intravesical Instillation in Patients With Intermediate and High-risk Non-muscle Invasive Bladder Cancer: a Multi-center, Single-arm Clinical Study

Clinical Trial Summary

This is a multicenter, single-arm study to evaluate the efficacy and safety of Pseudomonas aeruginosa the treatment of patients with intermediate and high risk non-muscle invasive bladder cancer. The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.

Clinical Trial Description

This study used a multicenter open single-arm study design. Study start: March 2023 Study end: March 2024 Multi-center: Three centers were selected to conduct the study to avoid differences in efficacy due to differences in operation among centers. Single-arm study: A total of 63 subjects with intermediate-high risk NMIBC who were scheduled for transurethral resection of bladder tumor (TURBT) from March 2023 in three centers were enrolled in this study. The enrolled patients received submucosal injection of 1U of Pseudomonas aeruginosa injection and bladder irrigation with chemotherapy drugs (gemcitabine, mitomycin C, epirubicin or pirarubicin) immediately after TURBT. After urine was cleared, a sterile urinary catheter was placed, and 10U of Pseudomonas aeruginosa injection and 40ml of normal saline were injected. The perfusion solution was kept for 1 hour, and the position was changed every 20 minutes. The treatment was given once within 24 hours after operation, then once a week for 12 weeks, and then once a month for 12 months in total. Patients were followed up every 3 months after surgery. The last follow-up was completed in February 2025. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05975151
Study type Interventional
Source Qilu Hospital of Shandong University
Contact Benkang Shi, Dr.
Phone 18560083917
Email bkang68@sdu.edu.cn
Status Recruiting
Phase Phase 2
Start date October 1, 2023
Completion date December 1, 2025
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