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

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: atezolizumab plus bevacizumab

• Registration Number: NCT05197504
• Lead Sponsor: CHA University

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

Study Timeline

• Study Start: 2021-12-20
• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intervention	atezolizumab plus bevacizumab	atezolizumab + bevacizumab

Primary Outcome Measures

Name	Time	Method
collected tumor samples	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	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 Outcome Measures

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

Trial Locations

Locations (1)

CHA Bundang Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of