Evaluation of Postoperative Adjuvant Chemotherapy Efficacy for Bladder Cancer Based on Organoid Technology.

Summary

To evaluate the clinical efficacy of using tumor organoid drug sensitivity experiments to guide postoperative adjuvant chemotherapy in patients with muscle-invasive bladder cancer, and to assess the application value of tumor organoid drug sensitivity experiments in guiding individualized postoperative adjuvant chemotherapy for muscle-invasive bladder cancer.

Eligibility

Inclusion Criteria:

* 1\. Age between 18 and 80 years, any gender; 2. For patients undergoing radical cystectomy, if the pathology meets inclusion criterion No. 3, tissue from the surgical specimen will be used for organoid culture; 3. Patients with pT3-pT4 and/or lymph node-positive MIBC who require adjuvant chemotherapy after surgery; 4. Patients who can tolerate platinum-based chemotherapy; 5. ECOG performance status of 0-2; 6. According to the investigator's judgment, able to comply with the study protocol, demonstrate good adherence, cooperate with the monitoring of adverse events and efficacy, and comply with follow-up; 7. Willing to voluntarily participate in this clinical trial, understand the study procedures, and have signed the informed consent form to participate in this study.

Exclusion Criteria:

* 1\. Severe, life-threatening complications occurring after radical cystectomy, such as cardiovascular complications, renal failure, respiratory failure, liver failure, sepsis, pulmonary embolism, and major hemorrhage; 2. Individuals with immunodeficiency or impairment (e.g., patients with AIDS, or those receiving immunosuppressants or radiotherapy); 3. Participants known to be allergic to the study drug, similar drugs, or excipients, or those with an allergic constitution; 4. Individuals taking long-term corticosteroids or with a history of drug abuse or dependence; 5. Individuals planning pregnancy soon, currently pregnant, or breastfeeding; 6. Abnormal blood routine, liver and kidney function, and coagulation indices (considered abnormal if one or more of the following are met):

  1. Absolute neutrophil count (ANC) ≤ 1.5 × 10⁹/L;
  2. White blood cell count (WBC) ≤ 3.0 × 10⁹/L;
  3. Platelet count (PLT) ≤ 90 × 10⁹/L;
  4. Hemoglobin (HB) ≤ 90 g/L;
  5. Total bilirubin (TBIL) ≥ 1.5 × upper limit of normal (ULN) for the institution;
  6. Estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m²;
  7. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≥ ULN (excluding patients on anticoagulant therapy, if considered clinically acceptable by the investigator); 7. Other factors that may cause the study to be prematurely terminated, such as:

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  1. Patients with a past or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
  2. A history of clear neurological or psychiatric disorders, including epilepsy or dementia;
  3. Comorbidities that pose a serious risk to patient safety or could affect study completion (e.g., severe hypertension, diabetes, thyroid disorders, etc.);
  4. Other serious diseases requiring combined treatment or with severe laboratory abnormalities;
  5. Other serious diseases accompanied by familial or social factors that could affect participant safety, or the collection of data and samples;
  6. Uncontrolled comorbid conditions, including but not limited to ongoing or active infections requiring treatment, symptomatic congestive heart failure, unstable angina, or arrhythmias; 8. Individuals deemed by the investigator as unsuitable to participate in the study.

Conditions2

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