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

Recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT03612726
• Lead Sponsor: Humanity & Health Medical Group Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-16
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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.
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)

Trial Locations

Locations (3)

Tokyo University; 🇯🇵 Tokyo, Japan

Beijing 302 Hospital; 🇨🇳 Beijing, China

Humanity & Health Medical Group Limited; 🇭🇰 Hong Kong, Hong Kong