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

NCT03612726 | Recruiting DMC

• 1 other identifier: APASL_HCC_2018V1
• Study Type: observational
• Target: 5,000
• Locations: 3 countries
• Sites: 3

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-free survival (PFS)

  Up to 5 years

• Time to progression (TTP)

  Up to 5 years

• Duration of treatment

  Up to 5 years

• Frequency and Severity of Adverse Events

  Up to 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Unresectable HCC who are treated under real-life clinical practice conditions in Asian Pacific Region

You may qualify if:

• Patients with a diagnosis of unresectable hepatocellular carcinoma
• Able to comprehend and provide written informed consent in accordance with institutional guidelines.

You may not qualify if:

• Patients not willing to participate and/or give their written informed consent.

Sponsors & Collaborators

• Humanity & Health Medical Group Limited: lead
• Tokyo University: collaborator

Study Sites (3)

Beijing 302 Hospital

Beijing, China

RECRUITING

Humanity & Health Medical Group Limited

Hong Kong, Hong Kong

RECRUITING

Tokyo University

Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Masao Omata, PhD, MD

  Tokyo University

  STUDY CHAIR

• George Lau, MD

  Humanity & Health Medical Group Limited

  STUDY CHAIR

Central Study Contacts

Danny Wang, PhD

CONTACT

+852-21160598; danny.wang@hnhmgl.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 2, 2018
• Study Start: July 16, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

HK (1); CN (1); JP (1)