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

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.

NCT Number	NCT07379268
Lead Sponsor	Qilu Hospital of Shandong University Collaborators: The Second Hospital of Shandong University, Qianfoshan Hospital, Shandong Provincial Hospital, Shandong Province Third hospital, Taian City Central Hospital, Weifang People's Hospital, Binzhou Medical University, The Affiliated Hospital of Qingdao University, Jining First People's Hospital, Liaocheng People's Hospital, Linyi People's Hospital, Yantai Yuhuangding Hospital, Zibo Central Hospital, Dezhou Hospital Qilu Hospital of Shandong University, Zaozhuang Municipal Hospital, Qilu Hospital of Shandong University (Qingdao)
Conditions	Bladder Cancer
Enrollment	224 participants
Start Date	2025-01-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-30