Overall Survival and Treatment Patterns for Advanced Hepatocellular Carcinoma Patients Who Received Second or Third Line Nivolumab Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,426
- 试验地点
- 1
- 主要终点
- Treatment patterns
研究概览
简要总结
A study to describe real-world treatment patterns and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy
详细描述
The central aims of this study are descriptive and designed to describe the patient demographics, clinical characteristics, treatment patterns, and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy in the real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult aHCC participants in the Flatiron database as defined by:
- •Diagnosed with HCC International Classification of Diseases (ICD)-9 155.x or ICD-10 C22.x)
- •Pathology consistent with advanced HCC
- •Age 18 years or older at index
- •At least two clinic encounters on different days in the Flatiron database occurring on or after January 1, 2011
- •Participants who received second or third line nivolumab monotherapy or combination therapy for aHCC
排除标准
- •Participants with <1 month of medical data (any clinic visits, medication administrations or oral medication prescriptions) following and including the index date
- •Participants with clinical study drug during prior or post study index periods
- •Other protocol-defined inclusion/exclusion criteria could apply
结局指标
主要结局
Treatment patterns
时间窗: From aHCC diagnosis date to first nivolumab treatment (Up to 7.75 years)
Nivolumab second and third lines of therapy will be described including prior lines of therapy, duration of nivolumab therapy and time from aHCC diagnosis date to first nivolumab treatment
Overall Survival
时间窗: From start date of 2L and 3L nivolumab therapy to the date of death (Up to 7.75 years)
The initial second or third line nivolumab therapy date will be used as the start date for the OS analysis. Occurrence of death will be considered as event and the duration for event will be calculated as time from 2L or 3L nivolumab therapy date to death date. Patients who survived will be censored and their duration period will be the time between the initial 2L or 3L nivolumab therapy date and the last date of their post-period follow up
次要结局
未报告次要终点