Biomarker Discovery Through Multiomics Study in Advanced Hepatocellular Carcinoma Patients Who Received Atezolizumab and Bevacizumab Combination Therapy
Overview
- Phase
- Not Applicable
- Intervention
- atezolizumab plus bevacizumab
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- CHA University
- Enrollment
- 166
- Locations
- 1
- Primary Endpoint
- collected tumor samples
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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
to establish multi-omics data and discover biomarkers highly associated with treatment response in HCC patients
Investigators
Hong Jae Chon
Assistant professor, Department of Medical Oncology
CHA University
Eligibility Criteria
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
Arms & Interventions
intervention
atezolizumab + bevacizumab
Intervention: atezolizumab plus bevacizumab
Outcomes
Primary Outcomes
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)
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
- Multi-omics analysis(3 years)
- Biomarkers on the efficacy of Atezolizumab+Bevacizumab for advanced HCC(3 years)