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

Phase 2

Recruiting

• Conditions: Bladder Cancer
• Interventions: Drug: Pseudomonas aeruginosa

• Registration Number: NCT05975151
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Detailed 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 Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-03
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Study Start: 2023-10-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pseudomonas aeruginosa Group	Pseudomonas aeruginosa	-

Primary Outcome Measures

Name	Time	Method
recurrence rate	1 year	Recurrence rate is determined on the basis of cystoscopy

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	1 year	Disease-free survival is defined as the time from the start of study treatment to disease recurrence or death from any cause

Trial Locations

Locations (1)

Qilu hospital; 🇨🇳 Jinan, Shandong, China