Clinical trial NCT05197504: Predictive Biomarkers in Patients With Advanced Hepatocellular Carcinoma Treated With Systemic Therapy
Official title: Biomarker Discovery Through Multiomics Study in Advanced Hepatocellular Carcinoma Patients Who Received Atezolizumab and Bevacizumab Combination Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced HCC will be recruited at CHA Bundang Medical Center

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

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

Primary outcomes:
measure: collected tumor samples
timeFrame: through study completion, an average of 3 years
measure: collected blood samples
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Multi-omics analysis
timeFrame: 3 years
measure: Biomarkers on the efficacy of Atezolizumab+Bevacizumab for advanced HCC
timeFrame: 3 years
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
affiliation: Principal Investigator
name: Hongjae Chon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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