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RecruitingNCT05173298HCCUpdated Feb 7, 2024

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

An observational study in Advanced Hepatocellular Carcinoma, sponsored by CHA University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by CHA University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Aug 2021; still recruiting 5 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
100
Ages
19 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Advanced Hepatocellular Carcinoma

Keywords

  • Hepatocellular carcinoma
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 100 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

CHA University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

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
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • analytic group

    advanced HCC Patients

    Drug: atezolizumab plus bevacizumab

Interventions

  • Drugatezolizumab plus bevacizumab

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

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What researchers measure

Primary outcomes

  1. collected tumor samples

    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)

    Time frame: through study completion, an average of 3 years

  2. collected blood samples

    blood samples from patients with hepatocellular carcinoma (incidence of Flow cytometry, ELISA analysis, single cell RNA sequencing, association with treatment response and survival duration

    Time frame: through study completion, an average of 3 years

Secondary outcomes

  1. Multi-omics analysis

    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.

    Time frame: 3 years

  2. Biomarkers on the efficacy of Atezolizumab+Bevacizumab for advanced HCC

    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.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • CHA Bundang Medical Center
    Seongnam-si, Gyeonggi-do 13496, Korea, Republic of
    Recruiting
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References and documents

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PubMed 33538338 ↗
  • Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1. PubMed 29433850 ↗
  • Zhu AX, Finn RS, Edeline J, Cattan S, Ogasawara S, Palmer D, Verslype C, Zagonel V, Fartoux L, Vogel A, Sarker D, Verset G, Chan SL, Knox J, Daniele B, Webber AL, Ebbinghaus SW, Ma J, Siegel AB, Cheng AL, Kudo M; KEYNOTE-224 investigators. Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial. Lancet Oncol. 2018 Jul;19(7):940-952. doi: 10.1016/S1470-2045(18)30351-6. Epub 2018 Jun 3. Erratum In: Lancet Oncol. 2018 Sep;19(9):e440. doi: 10.1016/S1470-2045(18)30612-0. PubMed 29875066 ↗
  • Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745. PubMed 32402160 ↗
  • Boyault S, Rickman DS, de Reynies A, Balabaud C, Rebouissou S, Jeannot E, Herault A, Saric J, Belghiti J, Franco D, Bioulac-Sage P, Laurent-Puig P, Zucman-Rossi J. Transcriptome classification of HCC is related to gene alterations and to new therapeutic targets. Hepatology. 2007 Jan;45(1):42-52. doi: 10.1002/hep.21467. PubMed 17187432 ↗
  • Hoshida Y, Toffanin S, Lachenmayer A, Villanueva A, Minguez B, Llovet JM. Molecular classification and novel targets in hepatocellular carcinoma: recent advancements. Semin Liver Dis. 2010 Feb;30(1):35-51. doi: 10.1055/s-0030-1247131. Epub 2010 Feb 19. PubMed 20175032 ↗
  • Llovet JM, Montal R, Sia D, Finn RS. Molecular therapies and precision medicine for hepatocellular carcinoma. Nat Rev Clin Oncol. 2018 Oct;15(10):599-616. doi: 10.1038/s41571-018-0073-4. PubMed 30061739 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05173298
Lead sponsor
CHA University
Collaborators
Boryung Pharmaceutical Co., Ltd
Responsible party
Hong Jae Chon (Assistant professor, Department of Medical Oncology, CHA University) — Principal investigator
First posted
Dec 29, 2021
Start date
Aug 2, 2021
Primary completion
Jul 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Feb 7, 2024

Study contacts

Hong Jae Chon, MD,PhD
Contact
minidoctor@cha.ac.kr
82-031-780-3928
Hongjae Chon, MD,PhD
principal investigator · Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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