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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: atezolizumab plus bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intervention<br>atezolizumab + bevacizumab | Drug: atezolizumab plus bevacizumab<br>* 1200 mg of atezolizumab plus 15 mg/kg of body weight of bevacizumab intravenously every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collected tumor samples | tumor samples from patients with hepatobiliary cancers (incidence of genetic alteration, association with treatment response and survival duration) | through study completion, an average of 3 years | 
| collected blood samples | blood samples from patients with hepatobiliary cancers (incidence of genetic alteration, association with treatment response and survival duration) | through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multi-omics analysis | Multi-omics analysis to further subtype and find therapeutic targets of HCC | 3 years | 
| Biomarkers on the efficacy of Atezolizumab+Bevacizumab for advanced HCC | Molecular biomarker associated with overall survival, progression-free survival and objective response rate in patients who receive atezolizumab plus bevacizumab | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma