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

NCT05975151 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2023-09-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pseudomonas aeruginosa

A total of 63 subjects with intermediate and 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

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-08-01
Completion
2025-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975151 on ClinicalTrials.gov