Using Pseudomonas aeruginosa to treat non-muscle invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, single-arm study aims to evaluate the efficacy and safety of Pseudomonas aeruginosa in patients with intermediate and high-risk non-muscle invasive bladder cancer (NMIBC). A total of 63 subjects will receive submucosal injections of Pseudomonas aeruginosa and chemotherapy drugs immediately after undergoing transurethral resection of bladder tumor (TURBT). The treatment regimen includes weekly injections for 12 weeks followed by monthly treatments for a year, with follow-ups every three months post-surgery. The study is designed to assess clinical benefits and monitor for any intolerable side effects.

Why it matters

Who can join: the full rules

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;

Where it's running

• Qilu hospital
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Benkang Shi, Dr.
• Email: bkang68@sdu.edu.cn
• Phone: 18560083917

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.