The Overall Survival of Patients With Unresectable HCC in Real-life
March 21, 2025 updated by: Humanity & Health Medical Group Limited
The Overall Survival of Patients Diagnosed With Unresectable Hepatocellular Carcinoma Under Real-life Clinical Practice in Asia Pacific Region
Liver cancer is the fifth most common cancer and the second most frequent cause of cancer-related death globally. Hepatocellular carcinoma represents about 90% of primary liver cancers and constitutes a major global health problem. The pattern of HCC occurrence shows a significant geographical imbalance, with the highest incidence rates in East Asia (more than 50% of the cases occurring in China).
The aim of this study is to investigate the overall survival (OS) of patients diagnosed with unresectable hepatocellular carcinoma under real-world practice conditions in Asia Pacific region.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Danny Wang, PhD
- Phone Number: +852-21160598
- Email: danny.wang@hnhmgl.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with Unresectable HCC who are treated under real-life clinical practice conditions in Asian Pacific Region
Description
Inclusion Criteria:
- Patients with a diagnosis of unresectable hepatocellular carcinoma
- Able to comprehend and provide written informed consent in accordance with institutional guidelines.
Exclusion Criteria:
- Patients not willing to participate and/or give their written informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: Up to 5 years
|
Overall survival (OS) is defined as the time (days) from the date of unresectable HCC diagnosis to the date of death, due to any reason.
Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival (PFS)
Time Frame: Up to 5 years
|
Progression-free survival (PFS) is defined as the time (days) from the start of treatment to the date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented
|
Up to 5 years
|
|
Time to progression (TTP)
Time Frame: Up to 5 years
|
Time to progression (TTP) is defined as the time (days) from the start of treatment to the first documented disease progression
|
Up to 5 years
|
|
Duration of treatment
Time Frame: Up to 5 years
|
Duration of treatment, defined by the time interval from the start of treatment to the day of permanent discontinuation of treatment (including death)
|
Up to 5 years
|
|
Frequency and Severity of Adverse Events
Time Frame: Up to 5 years
|
Safety will be evaluated by monitoring and recording the grade 3, 4 and 5 adverse events (AE) occurring during and after treatment throughout follow up of patients.
|
Up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Masao Omata, PhD, MD, Tokyo University
- Study Chair: George Lau, MD, Humanity & Health Medical Group Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2018
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
July 17, 2018
First Submitted That Met QC Criteria
July 27, 2018
First Posted (Actual)
August 2, 2018
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 21, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APASL_HCC_2018V1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.