An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation of Initial Treatment Pattern and Overall Survival in the Chinese Muscle Invasive Urothelial Bladder Carcinoma Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- the prevalence of High PD-L1 expression in the MIUBC patients
研究概览
简要总结
The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.
详细描述
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 positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
Note: PD-L1 High (>=25% tumor cell membrane positivity for PD-L1 or 1) IF IC area >1%: >=25% tumor associated immune cell positivity for PD-L1; 2) If IC area=1%: 100% tumor associated immune cell positivity for PD-L1). PD-L1 Low if criteria not met for PD-L1 High.
The second objectives of this observational study are:
- To investigate the PD-L1 expression profile in TC or IC in Chinese MIUBC patients.
- To assess the concordance of PD-L1 testing results generated from the hospital labs with those from the central lab.
- To observe the initial treatment pattern for MIUBC patients in usual clinical practice in China.
- To observe 2-year OS of the Chinese MIUBC patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
the prevalence of High PD-L1 expression in the MIUBC patients
时间窗: Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
Tumor tissue will be collected from all eligible patients who sign the ICF. Samples will be tested for PD-L1 expression status.
次要结局
- PD-L1 testing concordance between central lab and hospital labs(Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.)
- Proportion of patients with different PD-L1 expression level(Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.)
- Distribution percent of different treatment approaches(enrollment visit)
- 2-year OS(From enrollment to OS, up to 2 years)