Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,533
- 试验地点
- 34
- 主要终点
- Recurrence rate
研究概览
简要总结
The INSIGHT ('Insight into Real-world Practice of Management of HCC in Asia-Pacific') registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with HCC between 1st January 2013 and 31st December 2019 in nine countries (i.e., South Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore). Approximately 30% of the sample size will be identified retrospectively and 70% will be identified prospectively from the start date of the registry (October 2016), with an even distribution of consecutively diagnosed patients within the different years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male aged 21 or above.
- •Patient with confirmed diagnosis of HCC between 1st January 2013 and 31st December 2019 based on one or more of the following criteria:
- •American Association for the Study of Liver Diseases (AASLD) criteria
- •Asian Pacific Association for the Study of the Liver (APASL) criteria
- •Histology/cytology
- •Space occupying lesion in the liver and an serum alpha-feto protein of > 400 ng/mL in a patient with chronic viral hepatitis or cirrhosis from any cause
- •Informed consent form (ICF) to be presented and signed by patients who are still alive at the point of study enrolment, per local regulations. For the collection of data for deceased subjects, appropriate waiver of consent as per local regulations and guidelines will have to be in place.
- •Patient who is being followed-up at the participating site.
排除标准
- •Patients participating in any HCC-related therapeutic/interventional clinical trial.
结局指标
主要结局
Recurrence rate
时间窗: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
The proportion of patients who experience a recurrence of HCC after having had a CR to treatment
Disease Control Rate (DCR)
时间窗: From treatment initiation to SD, CR or PR, up to 2 years
The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC
Disease Free Survival (DFS)
时间窗: From the time from completing adjuvant/neoadjuvant treatment to the date of HCC recurrence, or the date of death due to any cause, whichever occurred first, up to 2 years
Patients lost for follow up will be censored at the last disease assessment date; DFS rate at 2 years - defined as the proportion of HCC patients who are alive and cancer free 2 years after completion of adjuvant/neoadjuvant treatment
Best Overall Response Rate (BORR)
时间窗: From treatment initiation to CR or PR, up to 2 years
The proportion of patients who had either a complete response (CR) or partial response (PR) after initiation of treatment for HCC
Overall Survival
时间窗: From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years
Progression-free survival
时间窗: From treatment initiation for advanced or metastatic HCC to the first date of disease progression or death due to any cause, whichever occurred first, up to 2 years
Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date
Time to progression
时间窗: From the start of treatment for a disease until disease progression, up to 2 years
Measuring the time to progression is one way to see how well a new treatment works. Also called TTP.
Overall Survival Rate
时间窗: 5 years from date of diagnosis
The percentage of people in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment. Also called survival rate.
Sites of recurrence
时间窗: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
local/ regional / distant; specify site(s)
Time to treatment recurrence
时间窗: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
次要结局
未报告次要终点