Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive … (NCT05975151) | Clinical Trial Compass
UnknownPhase 2
Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
China63 participantsStarted 2023-10-01
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;