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

Prior treatment

• Immunodeficient or damaged individuals (e.g., AIDS patients, patients on immunosuppressive drugs or radiotherapy);

Other illness

• bladder perforation during TURBT, postoperative gross haematuria, symptomatic severe chemical cystitis, and urinary tract infection;
• Subjects with known allergies or sensitivities to the study drug, analogues, excipients, etc.
• Subjects who have been taking hormonal drugs for a long period of time or have a history of drug abuse and dependence

Lab values

• 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)
• 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.

Other

• Those who have recent pregnancy plans or are already pregnant or breastfeeding;
• In the opinion of the investigator, not suitable for participation in this study.

• Age 18-80 years old, gender is not limited;
• Patients with intermediate-risk and high-risk non-muscle invasive bladder cancer (NMIBC) requiring bladder perfusion therapy;
• No prior bladder perfusion therapy (except immediate postoperative perfusion);
• ECOG status score of 0-2;
• 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;
• Voluntarily participate in this clinical trial, understand the study procedures and have signed the informed consent to participate in this study;