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Trial Title:
Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
NCT ID:
NCT05975151
Condition:
Bladder Cancer
Conditions: Official terms:
Pseudomonas Infections
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
bladder cancer
NMIBC
Pseudomonas aeruginosa
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pseudomonas aeruginosa
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
Arm group label:
Pseudomonas aeruginosa Group
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.
Criteria for eligibility:
Criteria:
Inclusion criteria:
1. Age ≥18 years old, both male and female;
2. 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);
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu hospital
Address:
City:
Jinan
Zip:
276600
Country:
China
Status:
Recruiting
Contact:
Last name:
Benkang Shi
Phone:
bkang68@sdu.edu.cn
Email:
bkang68@sdu.edu.cn
Start date:
October 1, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05975151
