Status:
COMPLETED
An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation in the Chinese MIUBC Patients.
Lead Sponsor:
AstraZeneca
Conditions:
Urinary Bladder Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.
Detailed Description
The primary objective of this observational study is: •To investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients. High PD-L1 expression is defined as ≥25% tumor cell membrane p...
Eligibility Criteria
Inclusion
- Age ≥18 years at the time of screening.
- Be able and willing to sign the informed consent form (ICF).
- Patients with histologically or cytologically documented, muscle invasive urothelial carcinoma (ie, T2 toT4, any N, any M) of bladder (see National Comprehensive Cancer Network \[NCCN\] Bladder Cancer Guidelines), who had not been previously treated with any systemic chemotherapy, radiotherapy, investigational product, or biologic therapy for cancer treatment.
- For PD-L1 testing by IHC assay, all patients were able to provide a newly acquired tumor sample within 60 days before enrollment by cystectomy, transurethral resection or biopsy. Samples with limited tumor content and fine needle aspirate specimens were not acceptable. Specimens from metastatic bone lesions were typically unacceptable unless there was a significant soft tissue component. The tumor specimen submitted to establish PD-L1 status should be of sufficient quantity to allow for PD-L1 IHC analyses and was preferred in FFPE blocks.
Exclusion
- Prior acquiring tumor tissue samples exposure to immune-mediated therapy (including Bacillus Calmette Guerin), including but not limited to, any anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, therapeutic anticancer vaccines.
- Any concurrent chemotherapy, investigational product, or biologic therapy for cancer treatment. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent was acceptable (eg, local surgery or radiotherapy).
Key Trial Info
Start Date :
May 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 27 2023
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT03433924
Start Date
May 18 2020
End Date
March 27 2023
Last Update
March 27 2024
Active Locations (17)
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1
Research Site
Beijing, China, 100034
2
Research Site
Beijing, China, 100730
3
Research Site
Changchun, China, 130021
4
Research Site
Changsha, China, 410013