Evaluation of the Efficacy of Anti-HER2 Antibody-Drug Conjugates (ADC) in Locally Advanced or Metastatic Bladder Cancer Based on Organoid Technology.

Recruiting now

Conditions studied: Bladder Cancer

In brief

This study, through a clinical controlled trial, compares the one-year, two-year, and three-year overall survival rates of patients in the treatment group guided by organoid drug sensitivity intervention with those of patients whose medication was based on HER-2 protein expression levels (IHC method). Univariate Kaplan-Meier survival analysis was used to compare differences in overall survival between the two groups. The study aims to evaluate the application value of tumor organoid drug sensitivity testing in guiding anti-HER2-ADC drug treatment for bladder cancer.

Key facts

Study ID: NCT07379268
Run by: Qilu Hospital of Shandong University
People needed: 224
Starts: 2025-01-01
Expected to finish: 2028-12-31
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. All bladder cancer patients to be included in the study must meet the inclusion criteria in item 3 regarding staging, and tumor biopsy tissue taken before ADC treatment will be used for organoid culture; 3. Patients with unresectable locally advanced (cT4b and/or N2-3) or metastatic bladder cancer (M1) who have failed platinum-based chemotherapy; 4. Patients who have shown disease progression after at least one round of platinum-based chemotherapy, or have no satisfactory alternative treatment options; 5. Patients who can tolerate adverse reactions from ADC drug enfortumab vedotin treatment; 6. ECOG performance status score of 0-2; 7. Judged by the investigator to be able to comply with the trial protocol, have good adherence, cooperate in monitoring adverse events and efficacy, and participate in follow-up; 8. 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 locally advanced or metastatic bladder cancer who have not previously received platinum-containing chemotherapy; 2. Individuals with immunodeficiency or impairment (e.g., patients with AIDS, or those using immunosuppressants or undergoing radiotherapy); 3. Participants known to be allergic to the investigational drug, similar drugs, or excipients, or those with allergic constitution; 4. Individuals on long-term steroid medication or with a history of drug abuse or dependence; 5. Those who are planning to become pregnant, are currently pregnant, or are breastfeeding; 6. Individuals with abnormal blood routine, liver and kidney function, or coagulation indicators (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 × the upper limit of normal (ULN) of the institution;
Estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m²;
International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≥ ULN (except for patients receiving anticoagulant therapy, if considered clinically acceptable by the investigator); 7. Participants with other factors that may cause the study to be prematurely terminated, including:
History or current diagnosis of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML);
History of clear neurological or psychiatric disorders, including epilepsy or dementia;
Severe comorbidities that endanger patient safety or affect study completion (e.g., severe hypertension, diabetes, thyroid disorders);
Other serious diseases requiring concomitant treatment, with severe laboratory abnormalities;
Other serious diseases accompanied by family or social factors that could impact participant safety, or the collection of data and samples;
Uncontrolled comorbid conditions, including but not limited to persistent or active infections requiring treatment, symptomatic congestive heart failure, unstable angina, or arrhythmias; 8. Participants deemed unsuitable for this study by the investigator.

Where it is running

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

Full record on ClinicalTrials.gov

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