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

Sponsor
Humanity & Health Medical Group Limited (Other)
Overall Status
Recruiting
CT.gov ID
NCT03612726
Collaborator
Tokyo University (Other)
5,000
3
62.5
1666.7
26.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    The Overall Survival of Patients Diagnosed With Unresectable Hepatocellular Carcinoma Under Real-life Clinical Practice in Asia Pacific Region
    Actual Study Start Date :
    Jul 16, 2018
    Anticipated Primary Completion Date :
    Jul 31, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [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

    Secondary Outcome Measures

    1. Progression-free survival (PFS) [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

    2. Time to progression (TTP) [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

    3. Duration of treatment [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)

    4. Frequency and Severity of Adverse Events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing 302 Hospital Beijing China
    2 Humanity & Health Medical Group Limited Hong Kong Hong Kong
    3 Tokyo University Tokyo Japan

    Sponsors and Collaborators

    • Humanity & Health Medical Group Limited
    • Tokyo University

    Investigators

    • Study Chair: Masao Omata, PhD, MD, Tokyo University
    • Study Chair: George Lau, MD, Humanity & Health Medical Group Limited

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Humanity & Health Medical Group Limited
    ClinicalTrials.gov Identifier:
    NCT03612726
    Other Study ID Numbers:
    • APASL_HCC_2018V1
    First Posted:
    Aug 2, 2018
    Last Update Posted:
    Mar 17, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 17, 2022