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

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pseudomonas aeruginosa
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer, NMIBC, Pseudomonas aeruginosa

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Age ≥18 years old, both male and female; Diagnosed as Intermediate 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); Not receiving BCG or other immune drug infusion chemotherapy at the same time Informed consent and signed informed consent form by patients and their families; Clear consciousness and able to answer questions independently, Patients were asked to complete the questionnaire by themselves; No history of neurological diseases, severe hematological diseases, and dysfunction of heart, lung, liver, or kidney were observed. Exclusion criteria: Patients with other genitourinary system tumors or other organ tumors; Patients with muscle invasive bladder urothelial carcinoma (≥T2); Patients receiving chemotherapy, radiotherapy or immunotherapy within the past 4 weeks (excluding immediate postoperative intravesical chemotherapy); 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); Known or suspected intraoperative bladder perforation; Gross hematuria was present before enrollment, and the surgical wound was suspected to be unhealed or damaged urinary mucosa; Patients with cystitis, or previous treatment with other intravesical agents, whose bladder irritation significantly affected the evaluation of the study; Patients who had participated in a clinical trial with other drugs within 3 months before enrollment; Patients with known opioid or alcohol dependence; Patients with any condition considered by the investigators to increase the risk of the subject or interfere with the conduct of the trial;

Sites / Locations

  • Qilu hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pseudomonas aeruginosa Group

Arm Description

Outcomes

Primary Outcome Measures

recurrence rate
Recurrence rate is determined on the basis of cystoscopy

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2023
Last Updated
September 18, 2023
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT05975151
Brief Title
Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
bladder cancer, NMIBC, Pseudomonas aeruginosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pseudomonas aeruginosa Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pseudomonas aeruginosa
Intervention Description
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
Primary Outcome Measure Information:
Title
recurrence rate
Description
Recurrence rate is determined on the basis of cystoscopy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
Disease-free survival is defined as the time from the start of study treatment to disease recurrence or death from any cause
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
adverse event
Description
Adverse events including lower urinary tract symptoms, fever, and gastrointestinal reactions were evaluated according to laboratory and clinical tests (i.e., hematology and blood chemistry, urinalysis, and vital signs) during the observation period
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age ≥18 years old, both male and female; Diagnosed as Intermediate 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); Not receiving BCG or other immune drug infusion chemotherapy at the same time Informed consent and signed informed consent form by patients and their families; Clear consciousness and able to answer questions independently, Patients were asked to complete the questionnaire by themselves; No history of neurological diseases, severe hematological diseases, and dysfunction of heart, lung, liver, or kidney were observed. Exclusion criteria: Patients with other genitourinary system tumors or other organ tumors; Patients with muscle invasive bladder urothelial carcinoma (≥T2); Patients receiving chemotherapy, radiotherapy or immunotherapy within the past 4 weeks (excluding immediate postoperative intravesical chemotherapy); 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); Known or suspected intraoperative bladder perforation; Gross hematuria was present before enrollment, and the surgical wound was suspected to be unhealed or damaged urinary mucosa; Patients with cystitis, or previous treatment with other intravesical agents, whose bladder irritation significantly affected the evaluation of the study; Patients who had participated in a clinical trial with other drugs within 3 months before enrollment; Patients with known opioid or alcohol dependence; Patients with any condition considered by the investigators to increase the risk of the subject or interfere with the conduct of the trial;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benkang Shi, Dr.
Phone
18560083917
Email
bkang68@sdu.edu.cn
Facility Information:
Facility Name
Qilu hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
276600
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benkang Shi
Phone
bkang68@sdu.edu.cn
Email
bkang68@sdu.edu.cn

12. IPD Sharing Statement

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

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