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NCT Number: NCT03612726

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing 302 Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Danny Wang, PhD

CONTACT

[email protected]

+852-21160598

Sponsors and collaborators

Lead sponsor

Humanity & Health Medical Group Limited

Other

Collaborators

  • Tokyo University

Registry information

Official study title

The Overall Survival of Patients Diagnosed With Unresectable Hepatocellular Carcinoma Under Real-life Clinical Practice in Asia Pacific Region

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2018
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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