Using organoids to guide chemotherapy before bladder cancer surgery

Research Protocol for Evaluating the Efficacy of Neoadjuvant Chemotherapy Drugs for Muscle-Invasive Bladder Cancer Based on Organoid Technology.

This test tries to see if growing a patient's tumor as an organoid to pick neoadjuvant chemotherapy improves survival for people with muscle-invasive bladder cancer.

Quick facts

• Study type: Observational
• Enrollment: 254 (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)
• Trial ID: NCT07379281 on ClinicalTrials.gov

What this trial studies

Participants who are eligible for platinum-based neoadjuvant chemotherapy will have tumor tissue grown into organoids and undergo drug sensitivity testing to select a treatment plan. Those receiving organoid-guided plans are compared with patients receiving standard empirical neoadjuvant chemotherapy, with one-, three-, and five-year overall survival as primary outcomes. Survival differences are analyzed with Kaplan–Meier methods in a controlled, observational design. The protocol includes regular monitoring for treatment tolerance, adverse events, and follow-up after radical cystectomy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–80 with cT2–T4aNxM0 muscle-invasive bladder cancer who have not had prior systemic chemotherapy, have ECOG 0–2, and can tolerate platinum-based neoadjuvant treatment.

Not a fit: Patients with unresectable T4b disease, distant metastases, prior systemic chemotherapy, significant immunodeficiency, or who cannot tolerate surgery or platinum chemotherapy are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, organoid-guided selection could help pick the most effective pre-surgery chemotherapy, improving survival and reducing ineffective treatment and toxicity.

How similar studies have performed: Pilot and early clinical work in several cancers, including some preliminary bladder cancer reports, have shown promise for organoid-guided drug selection but definitive randomized evidence is still limited.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

  1\) 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 this trial is running

Jinan

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

Study contacts

• Study coordinator: Jun Chen

Conditions Bladder Cancer; Organoid