Exploring biomarkers in advanced liver cancer patients treated with atezolizumab and bevacizumab
Investigation of Predictive Biomarkers in Patients With Advanced Hepatocellular Carcinoma Treated With Atezolizumab Plus Bevacizumab
This study is trying to find out if certain biological markers in blood and tumor samples can help doctors understand how well advanced liver cancer patients respond to a combination treatment of atezolizumab and bevacizumab.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | CHA University Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab, atezoliozumab |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT05173298 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze multiomics data from patients with advanced hepatocellular carcinoma (HCC) who are receiving a combination of atezolizumab and bevacizumab. By examining peripheral blood and tumor tissue samples before and after treatment, the study seeks to identify biomarkers that correlate with treatment response. The research addresses the need for better classification and understanding of HCC, particularly in patients with underlying liver conditions. The findings could lead to more personalized treatment approaches for HCC patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 20 years old with unresectable advanced HCC who are planning to receive atezolizumab and bevacizumab therapy.
Not a fit: Patients with unstable systemic conditions or those unable to provide informed consent due to mental or neurological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of biomarkers that improve treatment response and outcomes for patients with advanced liver cancer.
How similar studies have performed: While several studies have explored gene mutations in advanced HCC, this study's focus on transcriptome analysis through RNA-sequencing represents a novel approach in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seongnam-si, Gyeonggi-do
- CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Hongjae Chon, MD,PhD — Principal Investigator
- Study coordinator: Hong Jae Chon, MD,PhD
- Email: minidoctor@cha.ac.kr
- Phone: 82-031-780-3928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.