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

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05975151

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Drug: Pseudomonas aeruginosa	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pseudomonas aeruginosa Group	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

Arm

Intervention/Treatment

Experimental: Pseudomonas aeruginosa Group

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

Outcome Measures

Primary Outcome Measures

recurrence rate [1 year]
Recurrence rate is determined on the basis of cystoscopy

Secondary Outcome Measures

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

Other Outcome Measures

adverse event [2 year]
Laboratory and clinical tests are used to assess adverse events during the observation period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria: (1) age ≥18 years old, both male and female; (2) diagnosed as medium or high risk non-muscle invasive bladder cancer, with previous recurrent pathological diagnosis report and cystoscopy available. Intermediate risk was defined as the presence of one or two of the following: multiple tumors, single tumor larger than 3cm, and/or recurrence (≥1 event in low-risk NMIBC within 1 year after diagnosis). High risk was defined as meeting any one of the following: T1 tumor, G3 tumor, carcinoma in situ (CIS), multiple, recurrent and large (> 3cm) TaG1G2/ low-risk tumor (simultaneous) (3) not receiving BCG or other immune drug infusion chemotherapy at the same time (4) informed consent and signed informed consent form by patients and their families (5) clear consciousness and able to answer questions independently, Patients were asked to complete the questionnaire by themselves. (6) No history of neurological diseases, severe hematological diseases, and dysfunction of heart, lung, liver, or kidney were observed.

Exclusion criteria: (1) Patients with other genitourinary system tumors or other organ tumors (2) patients with muscle invasive bladder urothelial carcinoma (≥T2) (3) patients receiving chemotherapy, radiotherapy or immunotherapy within the past 4 weeks (excluding immediate postoperative intravesical chemotherapy) (4) pregnant or lactating women, women of childbearing age who did not use effective contraception, and those who planned to become pregnant during the trial (including the partner of male subjects) (5) known or suspected intraoperative bladder perforation (6) gross hematuria was present before enrollment, and the surgical wound was suspected to be unhealed or damaged urinary mucosa (7) patients with cystitis, or previous treatment with other intravesical agents, whose bladder irritation significantly affected the evaluation of the study (8) patients who had participated in a clinical trial with other drugs within 3 months before enrollment (9) patients with known opioid or alcohol dependence (10) patients with any condition considered by the investigators to increase the risk of the subject or interfere with the conduct of the trial.