Evaluating the Efficacy of Neoadjuvant Chemotherapy Drugs Based on Organoid Technology

Recruiting now

Conditions studied: Bladder Cancer

In brief

This study, through a clinical controlled trial, compared the one-year, three-year, and five-year overall survival rates between patients receiving a treatment plan guided by organoid drug sensitivity and those receiving conventional empirical treatment. Univariate Kaplan-Meier survival analysis was used to compare the differences in overall survival between the two groups. The study aimed to evaluate the application value of tumor organoid drug sensitivity testing in guiding neoadjuvant chemotherapy for bladder cancer.

Key facts

Study ID

NCT07379281

Run by

Qilu Hospital of Shandong University

People needed

254

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 18-80 years, any gender; 2. Patients with cT2\~4aNxM0 MIBC who need neoadjuvant chemotherapy; 3. Patients who have not previously received systemic chemotherapy; 4. Patients who can tolerate platinum-based combination neoadjuvant chemotherapy; 5. ECOG performance status of 0-2; 6. According to the investigator's judgment, able to comply with the trial protocol, have good adherence, can cooperate in monitoring adverse events and efficacy, and participate in follow-up; 7. Voluntarily participate in this clinical trial, understand the study procedures, and have signed the informed consent form for participation.

You may not qualify if…

• 1. Patients with muscle-invasive bladder cancer (MIBC) with clinical stage T4b or distant metastasis, or the patient's physical condition is assessed to be intolerable to radical cystectomy; 2. Immunodeficiency or damage (such as AIDS patients, patients on immunosuppressants or radiotherapy); 3. Study participants who are known to be allergic or allergic to study drugs, similar drugs, excipients; 4. Those who have been taking hormonal drugs for a long time or have a history of drug abuse and dependence; 5. Those who have recently planned to become pregnant or are already pregnant or breastfeeding; 6. Abnormal blood routine, liver and kidney function and coagulation indicators: (1 or more can be considered abnormal)
• 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) ≤90g/L; 5) Total bilirubin (TBIL) ≥1.5 × institutional upper limit of normal (ULN); 6) Estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m²; 7) International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≥ULN (except for patients receiving anticoagulant therapy, which need to be considered clinically acceptable by the investigator); 7. Study participants have other factors that could cause forced termination of this study, such as: 7) Patients have a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 8) Previous history of definite neurological or psychiatric disorders, including epilepsy or dementia; 9) Concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (such as severe hypertension, diabetes, thyroid disease, etc.); 10) Other serious diseases require combined treatment, with serious laboratory abnormalities; 11) Other serious diseases accompanied by family or social factors that will affect the safety of research participants, or the collection of data and samples, etc.; 12) Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, or arrhythmia; 8. Those who are not suitable to participate in this study in the opinion of the investigator.

Where it is running

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

Full record on ClinicalTrials.gov

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