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.
Study Type
OBSERVATIONAL
Enrollment
2,533
Overall Survival
Time frame: 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
Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date
Time frame: 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
Time to progression
Measuring the time to progression is one way to see how well a new treatment works. Also called TTP.
Time frame: From the start of treatment for a disease until disease progression, up to 2 years
Overall Survival Rate
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.
Time frame: 5 years from date of diagnosis
Best Overall Response Rate (BORR)
The proportion of patients who had either a complete response (CR) or partial response (PR) after initiation of treatment for HCC
Time frame: From treatment initiation to CR or PR, up to 2 years
Disease Control Rate (DCR)
The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC
Time frame: From treatment initiation to SD, CR or PR, up to 2 years
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Southwest Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China
Guangxi Medical University Cancer Center
Nanning, Guangxi, China
Nanjing Bayi Hospital
Nanjing, Jiangsu, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Queen Mary Hospital
Hong Kong, Hong Kong
...and 24 more locations
Disease Free Survival (DFS)
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
Time frame: 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
Recurrence rate
The proportion of patients who experience a recurrence of HCC after having had a CR to treatment
Time frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
Sites of recurrence
local/ regional / distant; specify site(s)
Time frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
Time to treatment recurrence
Time frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years