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

NCT05197504 | Completed

• 1 other identifier: 2021-11-019
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (2)

• collected tumor samples

  tumor samples from patients with hepatobiliary cancers (incidence of genetic alteration, association with treatment response and survival duration)

  through study completion, an average of 3 years

• collected blood samples

  blood samples from patients with hepatobiliary cancers (incidence of genetic alteration, 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)

intervention

atezolizumab + bevacizumab

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

intervention

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 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

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

Sponsors & Collaborators

• CHA University: lead

Study Sites (1)

CHA Bundang Medical Center

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

Location

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

Study Design

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

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 19, 2022
• Study Start: December 20, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)