A Research Protocol for Evaluating the Efficacy of Perfused Chemotherapeutic Agents for Bladder Cancer Based on Organoid Technology

Summary

The investigators are here to invite participants to participate in a medical research project, and this informed consent form provides participants with information to decide whether or not to participate in this study. Please read the following carefully and discuss any questions and terms that are not clear with the study doctor. The participants' participation in this study is completely voluntary and the project has been reviewed by the Research Ethics Committee of Qilu Hospital, Shandong University.

Eligibility

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.

Conditions2

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