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

A Research Protocol for Evaluating the Efficacy of Perfused Chemotherapeutic Agents for Bladder Cancer Based on Organoid technologyKYLL-202407-046-1

This study is testing a new way to deliver chemotherapy for people with non-muscle invasive bladder cancer to see if it helps prevent the cancer from coming back.

Quick facts

• Study type: Observational
• Enrollment: 293 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, doxorubicin
• Locations: 17 sites (Binzhou, Shandong and 16 other locations)
• Trial ID: NCT06662071 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with intermediate or high-risk non-muscle invasive bladder cancer who have not previously undergone bladder perfusion therapy.

Not a fit: Patients with bladder perforation, severe urinary tract infections, or those who are immunocompromised may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for patients with bladder cancer, potentially reducing recurrence rates.

How similar studies have performed: While there have been studies exploring bladder perfusion therapies, the use of organoid technology in this context is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Binzhou, Shandong and 16 other locations

• 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)
• The second hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Jining No.1 People's Hospital — Jining, Shandong, China (Recruiting)
• Liaocheng People's Hospital — Liaocheng, Shandong, China (Recruiting)
• Linyi People's Hospital — Linyi, Shandong, China (Recruiting)
• Qilu Hospital of Shandong University(Qing Dao) — Qingdao, Shandong, China (Recruiting)
• the Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
• Taian City Central Hospital — Taian, Shandong, China (Recruiting)
• Weifang People's Hospital — Weifang, Shandong, China (Recruiting)
• Yantai Yuhuanding Hospital — Yantai, Shandong, China (Recruiting)
• Zaozhuang Municipal Hospital — Zaozhuang, Shandong, China (Recruiting)
• Zibo Central Hospital — Zibo, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Jun Chen

Conditions Bladder Cancer; Organoid