Predictive Biomarkers in Patients With Advanced Hepatocellular Carcinoma Treated With Atezolizumab Plus Bevacizumab (HCC)

CHA University

Status

Enrolling

Conditions

Advanced Hepatocellular Carcinoma

Treatments

Drug: atezolizumab plus bevacizumab

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05173298

2021-07-080

Details and patient eligibility

About

The goal of this observational study is to learn about in patients with advanced hepatocellular carcinoma treated with atezoliozumab and bevacizumab.

In this clinical study, we intend to analyze the multiomics data by analyzing the peripheral blood and tumor tissue before and after treatment of patients with advanced liver cancer receiving systemic drug treatment, and analyzing the correlation with the treatment. This is an exploratory study that aims to discover biomarkers that are highly correlated with treatment response.

Full description

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 to establish multi-omics data and discover biomarkers highly associated with treatment response in HCC patients who received atezolizumab and bevacizumab combination.

Enrollment

100 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The following two groups will be integrated and analyzed. The criteria for both groups are the same.

Group 1. Prospective Group

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 planning to receive atezolizumab and bevacizumab combination therapy
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

Group 2. Retrospective Group

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 have received atezolizumab and bevacizumab combination therapy
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