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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03612726
• Other study ID #: APASL_HCC_2018V1
• Status: Recruiting
• Start date: July 16, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Humanity & Health Medical Group Limited
• Contact: Danny Wang, PhD
• Phone: +852-21160598
• Email: danny.wang[@]hnhmgl.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
China	Beijing 302 Hospital	Beijing
Hong Kong	Humanity & Health Medical Group Limited	Hong Kong
Japan	Tokyo University	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Humanity & Health Medical Group Limited	Tokyo University

Countries where clinical trial is conducted

China,  Hong Kong,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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	Progression-free survival (PFS)	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
Secondary	Time to progression (TTP)	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
Secondary	Duration of treatment	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
Secondary	Frequency and Severity of Adverse Events	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