Status:
UNKNOWN
Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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 ...
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 efficac...
Eligibility Criteria
Inclusion
- 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;
Exclusion
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05975151
Start Date
October 1 2023
End Date
December 1 2025
Last Update
September 21 2023
Active Locations (1)
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1
Qilu hospital
Jinan, Shandong, China, 276600