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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05197504
Acronym
HCC
Enrollment
166
Registered
2022-01-19
Start date
2021-12-20
Completion date
2023-12-31
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma

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

Interventions

1200 mg of atezolizumab plus 15 mg/kg of body weight of bevacizumab intravenously every 3 weeks

Sponsors

CHA University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
collected tumor samplesthrough study completion, an average of 3 yearstumor samples from patients with hepatobiliary cancers (incidence of genetic alteration, association with treatment response and survival duration)
collected blood samplesthrough study completion, an average of 3 yearsblood samples from patients with hepatobiliary cancers (incidence of genetic alteration, association with treatment response and survival duration)

Secondary

MeasureTime frameDescription
Multi-omics analysis3 yearsMulti-omics analysis to further subtype and find therapeutic targets of HCC
Biomarkers on the efficacy of Atezolizumab+Bevacizumab for advanced HCC3 yearsMolecular biomarker associated with overall survival, progression-free survival and objective response rate in patients who receive atezolizumab plus bevacizumab

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026