Tests tumor-grown lab models to guide bladder cancer chemotherapy after surgery
Uses lab-grown tumor models to guide chemotherapy choice in muscle-invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: Evaluation of Postoperative Adjuvant Chemotherapy Efficacy for Bladder Cancer Based on Organoid Technology.
Key facts
- Where
- Jinan, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07379255, who can take part
Where in China
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Hospital of Shandong University
- Trial code
- NCT07379255
- Record updated
- 30 January 2026
- Original description
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.Read full original descriptionShow less
Study Protocol for Evaluating the Efficacy of Postoperative Adjuvant Chemotherapy Drugs for Bladder Cancer Based on Organoid Technology.
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.
Inclusion: 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: 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:; <!-- -->; 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.