Clinical trial · Observational
Predictive Biomarkers in Patients With Advanced Hepatocellular Carcinoma Treated With Atezolizumab Plus Bevacizumab
Investigation of Predictive Biomarkers in Patients With Advanced Hepatocellular Carcinoma Treated With Atezolizumab Plus Bevacizumab
NCT05173298CI-TRIAL-00073778HCCunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| atezolizumab plus bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- analytic group
- description
- advanced HCC Patients
- interventionNames
- Drug: atezolizumab plus bevacizumab
Primary outcomes (2)
- measure
- collected tumor samples
- timeFrame
- through study completion, an average of 3 years
- description
- 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)
- measure
- collected blood samples
- timeFrame
- through study completion, an average of 3 years
- description
- blood samples from patients with hepatocellular carcinoma (incidence of Flow cytometry, ELISA analysis, single cell RNA sequencing, association with treatment response and survival duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDSung 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
- BACKGROUNDKudo 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
- BACKGROUNDZhu 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
- BACKGROUNDFinn 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
- BACKGROUNDBoyault 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
- 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.