Evaluating the effectiveness of new chemotherapy methods for bladder cancer using organoid technology

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 research project aims to assess the efficacy of perfused chemotherapeutic agents for treating non-muscle invasive bladder cancer (NMIBC) by utilizing organoid technology. Participants aged 18-80 with intermediate to high-risk NMIBC will be invited to undergo bladder perfusion therapy, which is crucial for preventing cancer recurrence. The study will involve careful monitoring of participants' responses to the treatment and any adverse effects. The project has received ethical approval and emphasizes voluntary participation and informed consent.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Age 18-80 years old, gender is not limited;
2. Patients with intermediate-risk and high-risk non-muscle invasive bladder cancer (NMIBC) requiring bladder perfusion therapy;
3. No prior bladder perfusion therapy (except immediate postoperative perfusion);
4. ECOG status score of 0-2;
5. Be able to comply with the trial protocol, have good compliance, cooperate in observing adverse events and efficacy and cooperate in follow-up, as judged by the investigator;
6. Voluntarily participate in this clinical trial, understand the study procedures and have signed the informed consent to participate in this study;

Exclusion criteria:

1. bladder perforation during TURBT, postoperative gross haematuria, symptomatic severe chemical cystitis, and urinary tract infection;
2. Immunodeficient or damaged individuals (e.g., AIDS patients, patients on immunosuppressive drugs or radiotherapy);
3. Subjects with known allergies or sensitivities to the study drug, analogues, excipients, etc.
4. Subjects who have been taking hormonal drugs for a long period of time or have a history of drug abuse and dependence
5. Those who have recent pregnancy plans or are already pregnant or breastfeeding;
6. Those with abnormal blood counts, liver and kidney functions and coagulation indexes: (fulfilling 1 or more can be considered abnormal)

   ① Neutrophil count (ANC) ≤1.5×10\*9/L;
   * white blood cell count (WBC) ≤ 3.0 × 10\*9 / L.

     * Platelet count (PLT) ≤90×10\*9/L;

       * Haemoglobin (HB) ≤90g/L; ⑤ Total bilirubin (TBIL) ≥1.5 × institutional upper limit of normal (ULN);

         * Estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73m²;

           * International Normalised Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≥ ULN (except for patients receiving anticoagulation therapy, subject to the investigator's opinion that this is a clinically acceptable outcome)
7. The subject has other factors that may force the study to be terminated mid-stream, such as:

   * The patient has a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML);

     * A previous history of a definite neurological or psychiatric disorder, including epilepsy or dementia;

       * Serious concomitant medical conditions (e.g., severe hypertension, diabetes mellitus, thyroid disease, etc.) that jeopardise patient safety, or interfere with the patient's ability to complete the study; ④ Other serious diseases requiring combination therapy, with serious laboratory test abnormalities; ⑤ Other serious diseases accompanied by family or social factors, etc., which will affect the safety of the subjects, or the collection of data and samples, etc; ⑥ Uncontrolled co-morbidities including, but not limited to, persistent or active infections requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmias.
8. In the opinion of the investigator, not suitable for participation in this study.

Where it's running

• Binzhou Medical University Hospital
  Binzhou, Shandong, China Recruiting
• Qilu Hospital of Shandong University Dezhou Hospital
  Dezhou, Shandong, China Recruiting
• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting
• Shandong Provincial Hospital Affiliated to Shandong First Medical University (Shandong Provincial Hospital)
  Jinan, Shandong, China Recruiting
• Shandong Third Hospital
  Jinan, Shandong, China Recruiting
• The First Affiliated Hospital Of Shandong First Medcial Unversity
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Jun Chen
• Email: chenjunxinxiang@163.com
• Phone: +86 18560084873

Similar studies

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.