Evaluation of the Efficacy of Anti-HER2 Antibody-Drug Conjugates (ADC) in Locally Advanced or Metastatic Bladder Cancer Based on Organoid Technology.

Exclusion Criteria15

• \. Patients with locally advanced or metastatic bladder cancer who have not previously received platinum-containing chemotherapy; 2. Individuals with immunodeficiency or impairment (e.g., patients with AIDS, or those using immunosuppressants or undergoing radiotherapy); 3. Participants known to be allergic to the investigational drug, similar drugs, or excipients, or those with allergic constitution; 4. Individuals on long-term steroid medication or with a history of drug abuse or dependence; 5. Those who are planning to become pregnant, are currently pregnant, or are breastfeeding; 6. Individuals with abnormal blood routine, liver and kidney function, or coagulation indicators (considered abnormal if one or more of the following are met):
• Absolute neutrophil count (ANC) ≤ 1.5 × 10⁹/L;
• White blood cell count (WBC) ≤ 3.0 × 10⁹/L;
• Platelet count (PLT) ≤ 90 × 10⁹/L;
• Hemoglobin (HB) ≤ 90 g/L;
• Total bilirubin (TBIL) ≥ 1.5 × the upper limit of normal (ULN) of the institution;
• Estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m²;
• International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≥ ULN (except for patients receiving anticoagulant therapy, if considered clinically acceptable by the investigator); 7. Participants with other factors that may cause the study to be prematurely terminated, including:
• <!-- -->
• History or current diagnosis of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML);
• History of clear neurological or psychiatric disorders, including epilepsy or dementia;
• Severe comorbidities that endanger patient safety or affect study completion (e.g., severe hypertension, diabetes, thyroid disorders);
• Other serious diseases requiring concomitant treatment, with severe laboratory abnormalities;
• Other serious diseases accompanied by family or social factors that could impact participant safety, or the collection of data and samples;
• Uncontrolled comorbid conditions, including but not limited to persistent or active infections requiring treatment, symptomatic congestive heart failure, unstable angina, or arrhythmias; 8. Participants deemed unsuitable for this study by the investigator.