Skip to main content
OpenTrials
Completed

NCT Number: NCT05197504

Predictive Biomarkers in Patients With Advanced Hepatocellular Carcinoma Treated With Systemic Therapy

Hepatocellular carcinoma (HCC) is the third most common cause of cancer-related deaths worldwide, and HCC is more frequently observed in Asia, including South Korea. As HCC is often accompanied by chronic hepatitis B or C virus and liver cirrhosis, treatment of HCC consider not only the tumor but also various factors such as liver function and the patient's performance status. Local treatment and surgery are possible in the early stages of HCC. However, it has a high recurrence rate even after curative surgeries due to underlying cirrhosis and the tumor microenvironment.

Although several studies have investigated gene mutations and differences in treatment response in advanced HCC through next-generation sequencing (NGS), studies on transcriptome analysis of advanced HCC through RNA-sequencing are hard to find, with a need for future research into precise classification and clinical significance of HCC based on multi-omics data.

Completed

Looking for future studies?

Notify Me

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

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

About this study

to establish multi-omics data and discover biomarkers highly associated with treatment response in HCC patients

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Those above the age of 20 who understand the purpose of the study and agree to participate in the collection of samples during the study.
  • Patients who have been diagnosed with unresectable advanced HCC through imaging, histological, or cytological tests.
  • Patients who underwent an NGS test with advanced HCC tissues
  • Patients who are scheduled to receive systemic treatment
  • Patients with measurable lesions based on RECIST v1.1
  • ECOG performance status 0 or 1
  • Patients with a life expectancy of at least three months

Exclusion criteria

  • Patients who have systemic conditions accompanied by instability of vital signs, such as infections or organ failure
  • Those with mental/neurological conditions or dementia who have difficulties understanding and completing the consent form
  • Those who are assessed as not suitable for this study, at the discretion of the researcher

Treatment and study plan

atezolizumab plus bevacizumab

Drug

1200 mg of atezolizumab plus 15 mg/kg of body weight of bevacizumab intravenously every 3 weeks

Primary outcomes

  1. collected tumor samples

    Time frame: through study completion, an average of 3 years

    tumor samples from patients with hepatobiliary cancers (incidence of genetic alteration, association with treatment response and survival duration)

  2. collected blood samples

    Time frame: through study completion, an average of 3 years

    blood samples from patients with hepatobiliary cancers (incidence of genetic alteration, association with treatment response and survival duration)

Secondary outcomes

  1. Multi-omics analysis

    Time frame: 3 years

    Multi-omics analysis to further subtype and find therapeutic targets of HCC

  2. Biomarkers on the efficacy of Atezolizumab+Bevacizumab for advanced HCC

    Time frame: 3 years

    Molecular biomarker associated with overall survival, progression-free survival and objective response rate in patients who receive atezolizumab plus bevacizumab

Sponsors and collaborators

Lead sponsor

CHA University

Other

Registry information

Official study title

Biomarker Discovery Through Multiomics Study in Advanced Hepatocellular Carcinoma Patients Who Received Atezolizumab and Bevacizumab Combination Therapy

Acronym: HCC

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 19, 2022
Registry last updated
Sep 5, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.