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

NCT05173298 | Recruiting

• 1 other identifier: 2021-07-080
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (2)

• 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)

  through study completion, an average of 3 years

• 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

  through study completion, an average of 3 years

Secondary Outcomes (2)

• Multi-omics analysis

  3 years

• Biomarkers on the efficacy of Atezolizumab+Bevacizumab for advanced HCC

  3 years

Study Arms (1)

analytic group

advanced HCC Patients

Drug: atezolizumab plus bevacizumab

Interventions

atezolizumab plus bevacizumab DRUG

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

analytic group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• CHA University: lead
• Boryung Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

RECRUITING

Related Publications (7)

• 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.

  PMID: 33538338 BACKGROUND

• 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.

  PMID: 29433850 BACKGROUND

• 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.

  PMID: 29875066 BACKGROUND

• 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.

  PMID: 32402160 BACKGROUND

• 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.

  PMID: 17187432 BACKGROUND

• 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.

  PMID: 20175032 BACKGROUND

• 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.

  PMID: 30061739 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, Blood

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hongjae Chon, MD,PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Jae Chon, MD,PhD

CONTACT

82-031-780-3928; minidoctor@cha.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Department of Medical Oncology

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 29, 2021
• Study Start: August 2, 2021
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)