Using tumor organoids to guide adjuvant chemotherapy after bladder cancer surgery

Study Protocol for Evaluating the Efficacy of Postoperative Adjuvant Chemotherapy Drugs for Bladder Cancer Based on Organoid Technology.

This project will test whether drug-sensitivity tests on tumor organoids can help choose the best adjuvant chemotherapy for people with muscle-invasive bladder cancer after radical cystectomy.

Quick facts

• Study type: Observational
• Enrollment: 266 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Drugs / interventions: chemotherapy, methotrexate, doxorubicin
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07379255 on ClinicalTrials.gov

What this trial studies

This observational study collects tumor tissue from patients with pT3–pT4 and/or lymph node–positive muscle-invasive bladder cancer after radical cystectomy and grows patient-derived organoids. Drug-sensitivity assays on these organoids are performed to inform selection of platinum-based adjuvant chemotherapy. Patients are followed for clinical outcomes, including recurrence, disease-free survival, and treatment tolerability, to compare organoid-guided decisions with standard approaches. The study aims to determine the practical application and clinical value of organoid-guided individualized postoperative chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–80 with pT3–pT4 and/or lymph node–positive M0 muscle-invasive bladder cancer who have had radical cystectomy, can tolerate platinum-based chemotherapy, and can provide tumor tissue and informed consent.

Not a fit: Patients who cannot tolerate platinum chemotherapy, have severe postoperative organ failure or life‑threatening complications, or lack adequate tumor tissue for organoid culture are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, organoid-guided chemotherapy could help tailor postoperative treatment to reduce recurrence and improve survival for high-risk muscle-invasive bladder cancer patients.

How similar studies have performed: Early pilot studies in bladder and other cancers have suggested organoid drug-sensitivity assays can predict individual responses, but large randomized trials proving clinical benefit remain limited.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

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

Study contacts

• Study coordinator: Jun Chen

Conditions Bladder Cancer; Organoid