Predictive Biomarkers in Patients With Advanced Hepatocellular Carcinoma Treated With Atezolizumab Plus Bevacizumab (HCC)

February 5, 2024 updated by: Hong Jae Chon, CHA University

Investigation of Predictive Biomarkers in Patients With Advanced Hepatocellular Carcinoma Treated With Atezolizumab Plus Bevacizumab

The goal of this observational study is to learn about in patients with advanced hepatocellular carcinoma treated with atezoliozumab and bevacizumab.

In this clinical study, we intend to analyze the multiomics data by analyzing the peripheral blood and tumor tissue before and after treatment of patients with advanced liver cancer receiving systemic drug treatment, and analyzing the correlation with the treatment. This is an exploratory study that aims to discover biomarkers that are highly correlated with treatment response.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 to establish multi-omics data and discover biomarkers highly associated with treatment response in HCC patients who received atezolizumab and bevacizumab combination.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
        • Recruiting
        • CHA Bundang Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced HCC will be recruited at CHA Bundang Medical Center

Description

The following two groups will be integrated and analyzed. The criteria for both groups are the same.

Group 1. Prospective Group

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 planning to receive atezolizumab and bevacizumab combination therapy
  • 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

Group 2. Retrospective Group

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 have received atezolizumab and bevacizumab combination therapy
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
analytic group
advanced HCC Patients
Drug: atezolizumab plus bevacizumab
1200 mg of atezolizumab plus 15 mg/kg of body weight of bevacizumab intravenously every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
collected tumor samples
Time Frame: through study completion, an average of 3 years
tumor samples from patients with hepatocellular carcinoma (incidence of analysis of the expression patterns of various immune response-related proteins through H&E staining, immunochemical staining, and immunofluorescent staining methods, association with treatment response and survival duration)
through study completion, an average of 3 years
collected blood samples
Time Frame: through study completion, an average of 3 years
blood samples from patients with hepatocellular carcinoma (incidence of Flow cytometry, ELISA analysis, single cell RNA sequencing, 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
Time Frame: 3 years
Multi-omics analysis to further subtype and find therapeutic targets of HCC Multi-omics analysis is a total and integrated analysis of various molecular levels such as dielectric and protein.
3 years
Biomarkers on the efficacy of Atezolizumab+Bevacizumab for advanced HCC
Time Frame: 3 years
Molecular biomarker associated with overall survival, progression-free survival and objective response rate in patients who receive atezolizumab plus bevacizumab A gene-based biomarker that predicts the therapeutic response of patients administered with Atezolizumab and Bevacizumab.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHA University

Collaborators

Boryung Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Hongjae Chon, MD,PhD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2021

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

December 12, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-07-080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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