The Overall Survival of Patients With Unresectable HCC in Real-life

February 26, 2024 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

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing 302 Hospital
        • Contact:
          • Guofeng Chen, MD
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Humanity & Health Medical Group Limited
        • Contact:
          • George Lau, MD
  • Japan
      • Tokyo, Japan
        • Recruiting
        • Tokyo University
        • Contact:
          • Masao Omata, PhD, MD

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.

Sponsor

Humanity & Health Medical Group Limited

Collaborators

Tokyo University

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)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

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.

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