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

Recruiting
Conditions
Advanced Hepatocellular Carcinoma
Interventions
Registration Number
NCT05173298
Lead Sponsor
CHA University
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
analytic groupatezolizumab plus bevacizumabadvanced HCC Patients
Primary Outcome Measures
NameTimeMethod
collected tumor samplesthrough study completion, an average of 3 years

tumor samples from patients with hepatocellular carcinoma (incidence of analysis of the expression patterns of various immune response-related proteins through H\&E staining, immunochemical staining, and immunofluorescent staining methods, association with treatment response and survival duration)

collected blood samplesthrough study completion, an average of 3 years

blood samples from patients with hepatocellular carcinoma (incidence of Flow cytometry, ELISA analysis, single cell RNA sequencing, association with treatment response and survival duration

Secondary Outcome Measures
NameTimeMethod
Multi-omics analysis3 years

Multi-omics analysis to further subtype and find therapeutic targets of HCC Multi-omics analysis is a total and integrated analysis of various molecular levels such as dielectric and protein.

Biomarkers on the efficacy of Atezolizumab+Bevacizumab for advanced HCC3 years

Molecular biomarker associated with overall survival, progression-free survival and objective response rate in patients who receive atezolizumab plus bevacizumab A gene-based biomarker that predicts the therapeutic response of patients administered with Atezolizumab and Bevacizumab.

Trial Locations

Locations (1)

CHA Bundang Medical Center

🇰🇷

Seongnam-si, Gyeonggi-do, Korea, Republic of

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