Predictive Biomarkers in Patients With Advanced Hepatocellular Carcinoma Treated With Atezolizumab Plus Bevacizumab
NCT ID: NCT05173298
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2021-08-02
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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analytic group
advanced HCC Patients
atezolizumab plus bevacizumab
1200 mg of atezolizumab plus 15 mg/kg of body weight of bevacizumab intravenously every 3 weeks
Interventions
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atezolizumab plus bevacizumab
1200 mg of atezolizumab plus 15 mg/kg of body weight of bevacizumab intravenously every 3 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
19 Years
ALL
No
Sponsors
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Boryung Pharmaceutical Co., Ltd
INDUSTRY
CHA University
OTHER
Responsible Party
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Hong Jae Chon
Assistant professor, Department of Medical Oncology
Principal Investigators
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Hongjae Chon, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2021-07-080
Identifier Type: -
Identifier Source: org_study_id
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