Clinical trial · Interventional
Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pseudomonas aeruginosa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pseudomonas aeruginosa Group
- interventionNames
- Drug: Pseudomonas aeruginosa
Primary outcomes (1)
- measure
- recurrence rate
- timeFrame
- 1 year
- description
- Recurrence rate is determined on the basis of cystoscopy
Secondary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 1 year
- description
- Disease-free survival is defined as the time from the start of study treatment to disease recurrence or death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available