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

Recruiting now

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT07379255

Run by

Qilu Hospital of Shandong University

People needed

266

Starts

2025-01-01

Expected to finish

2030-12-31

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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):
• 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 × upper limit of normal (ULN) for the institution;
• Estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m²;
• 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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• Patients with a past or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
• A history of clear neurological or psychiatric disorders, including epilepsy or dementia;
• Comorbidities that pose a serious risk to patient safety or could affect study completion (e.g., severe hypertension, diabetes, thyroid disorders, etc.);
• Other serious diseases requiring combined treatment or with severe laboratory abnormalities;
• Other serious diseases accompanied by familial or social factors that could affect participant safety, or the collection of data and samples;
• 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.

Where it is running

• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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