Using tumor organoids to guide adjuvant chemotherapy after bladder cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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:

  <!-- -->

  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 it's running

• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Jun Chen
• Email: chenjunxinxiang@163.com
• Phone: +86 18560084873

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

• Urinary Cell-Free DNA Test for Urothelial Cancer Origin

  This study tests a urine-based cell-free DNA test to help diagnose urothelial cancer and identify whether it started in the bladder or upper urinary tract in adults.

  Recruiting Ruijin Hospital · Shanghai · NCT07888374

• BL-M07D1: T-bren vs standard platinum chemo for HER2-expressing metastatic urothelial cancer after anti-PD-(L)1 therapy

  This trial tests whether T-bren can help people with HER2-expressing metastatic urothelial cancer who progressed after anti-PD-(L)1 therapy, compared with standard platinum-based chemotherapy.

  Recruiting at 2 sites Phase 3 SystImmune Inc. · Macon, Georgia and 1 other locations · NCT07869836

• Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

  This trial tests whether adding Sac-TMT and pembrolizumab to chemoradiation helps people with muscle-invasive bladder cancer live longer without the cancer growing or returning.

  Recruiting at 10 sites Phase 3 Merck Sharp & Dohme LLC · Kaohsiung City and 9 other locations · NCT07829783

• Personalized 3D Tumoroids from Your Tumor to Test Treatments

  Researchers are using patient tumor tissue and blood to grow personalized 3D, vascularized tumoroids with autologous immune cells to help tailor treatments for kidney, bladder, and prostate cancers.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07820566

• Irreversible Electroporation for Recurrent Pelvic Tumors

  This study tests whether using irreversible electroporation (IRE) is safe and helps control recurrent pelvic tumors in adults who can’t have other local treatments.

  Recruiting Amsterdam UMC, location VUmc · Amsterdam, North Holland · NCT07782164

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.