Actively Recruiting
Evaluation of the Efficacy of Anti-HER2 Antibody-Drug Conjugates (ADC) in Locally Advanced or Metastatic Bladder Cancer Based on Organoid Technology.
Led by Qilu Hospital of Shandong University · Updated on 2026-01-30
224
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
Q
Qilu Hospital of Shandong University
Lead Sponsor
T
The Second Hospital of Shandong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Efficacy of Anti-HER2 Antibody-Drug Conjugates (ADC) in Locally Advanced or Metastatic Bladder Cancer Based on Organoid Technology.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years, any gender
- Diagnosed with unresectable locally advanced (cT4b and/or N2-3) or metastatic bladder cancer (M1) who have failed platinum-based chemotherapy
- Disease progression after at least one round of platinum-based chemotherapy or no satisfactory alternative treatments
- Able to tolerate adverse reactions from ADC drug enfortumab vedotin treatment
- ECOG performance status score of 0-2
- Able to comply with trial protocol, adhere to monitoring adverse events and efficacy, and participate in follow-up
- Voluntarily agree to participate and have signed informed consent
- Tumor biopsy tissue available before ADC treatment for organoid culture
You will not qualify if you...
- No prior platinum-containing chemotherapy for locally advanced or metastatic bladder cancer
- Immunodeficiency or impairment (e.g., AIDS, immunosuppressants, radiotherapy)
- Known allergy to the investigational drug, similar drugs, excipients, or allergic constitution
- Long-term steroid medication or history of drug abuse or dependence
- Planning pregnancy, currently pregnant, or breastfeeding
- Abnormal blood routine, liver, kidney function, or coagulation indicators beyond specified thresholds
- History or current diagnosis of myelodysplastic syndromes or acute myeloid leukemia
- History of neurological or psychiatric disorders such as epilepsy or dementia
- Severe comorbidities affecting safety or study completion
- Other serious diseases requiring treatment or severe laboratory abnormalities
- Uncontrolled comorbid conditions including persistent infections, symptomatic heart failure, unstable angina, or arrhythmias
- Deemed unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
Research Team
J
Jun Chen
CONTACT
J
Jingchao Liu
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here