Hepatocellular CarcinomaNCT07186010
Immunogenomic Dynamics and Biomarkers in Patients With Hepatocellular Carcinoma Receiving Immunotherapy
An observational study of Hepatocellular Carcinoma and Liver Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
1. Research purpose To perform genomic and immune profiling analysis on blood and tissue samples obtained from blood sampling and tumor biopsy in patients with advanced hepatocellular carcinoma with immuno-oncology treatment. 2. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2020to 31 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically confirmed recurrent, locally advanced or metastatic HCC who will receive immuno-oncology treatment
Who may be able to join
- Patients with histologically confirmed HCC,
- Patients with histologically confirmed locally advanced, recurrent or metastatic HCC, which was judged not to be eligible for surgical resection, liver transplantation or radiofrequency ablation
- Patients who will receive immuno-oncology treatment
Who cannot join
- Patients with histologically confirmed fibrolamellar type HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Patients with concurrent other malignancy
- Patients who are candidates for local curative treatments such as hepatic resection, liver transplantation, or radiofrequency ablation
- Patients who have a possibility of confusion in the results of the clinical research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Song-pa, 05505
Ju Hyun Shim, 0230103190, s5854@amc.seoul.kr
About this study
- Research purpose To perform genomic and immune profiling analysis on blood and tissue samples obtained from blood sampling and tumor biopsy in patients with advanced hepatocellular carcinoma with immuno-oncology treatment.
- Research Subject Patients who will receive immuno-oncology treatment in recurrent, metastatic, and advanced liver cancer, who meet the selection criteria of the study, do not have exclusion criteria, and voluntarily agree to participate in the study.
- Number of study subjects 50 people
- Research Method 1) In patients with advanced hepatocellular carcinoma, peripheral blood will be collected at baseline before treatment, 6 weeks, 12 weeks, 24 weeks, 48 weeks after treatment, and at the time of cancer progression.
- Fresh tumors will be stored in the tissue obtained during the biopsy to perform genetic analysis
Read the detailed description
This study is designed to perform comprehensive genomic and immune profiling in patients with advanced hepatocellular carcinoma (HCC) undergoing immuno-oncology (IO) treatment. The objective is to investigate molecular and immunologic biomarkers in both blood and tumor tissue that may correlate with treatment response, disease progression, and clinical outcomes.
Eligible patients include those with recurrent, metastatic, or advanced HCC who are scheduled to receive IO therapy and who meet the study's inclusion and exclusion criteria. Approximately 50 participants will be enrolled.
Peripheral blood samples will be collected at predefined time points: prior to initiation of IO treatment (baseline), and at 6, 12, 24, and 48 weeks after treatment initiation, as well as at the time of disease progression. These blood samples will be subjected to genomic and immune profiling, including but not limited to circulating tumor DNA analysis, immune cell subset characterization, and cytokine/chemokine profiling.
In addition, fresh tumor tissue obtained from biopsy procedures will be stored and used for genetic and immunologic analyses. Tissue-based studies may include next-generation sequencing, immunohistochemistry, multiplex immunofluorescence, and other exploratory assays to evaluate tumor mutational landscape, immune checkpoint expression, and tumor microenvironmental features.
By integrating longitudinal blood-based biomarkers with tumor tissue data, this study aims to better characterize tumor biology, immune dynamics, and mechanisms of resistance in advanced HCC treated with immuno-oncology agents. The ultimate goal is to identify predictive and prognostic biomarkers that may guide personalized treatment strategies and improve clinical outcomes in this patient population.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Keywords
- immunotherapy, biomarker, HCC
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) according to RECIST 1.1 criteria
Proportion of participants achieving complete response (CR) or partial response (PR) as their best overall response, assessed by imaging according to RECIST 1.1 criteria.
Measured: from the date of the first immunotherapy date', every 9 weeks, for 2 years
Secondary outcomes (1)
overall survival
overall survival after initiation of immunotherapy
Measured: From date of immunotherapy until the date of death from any cause or study end whichever came first, assessed up to assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start28 Sep 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Hyun Shim, Asan Medical Center
- Investigators
- Ju Hyun Shim, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186010
- Sponsor's protocol ID
- KCT0005305
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenomic Dynamics and Biomarkers in Patients With Hepatocellular Carcinoma Receiving Immunotherapy
- ClinicalTrials.gov ID
- NCT07186010
- Acronym / sponsor ID
- KCT0005305
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Keywords
- immunotherapy, biomarker, HCC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Research purpose To perform genomic and immune profiling analysis on blood and tissue samples obtained from blood sampling and tumor biopsy in patients with advanced hepatocellular carcinoma with immuno-oncology treatment.
- Research Subject Patients who will receive immuno-oncology treatment in recurrent, metastatic, and advanced liver cancer, who meet the selection criteria of the study, do not have exclusion criteria, and voluntarily agree to participate in the study.
- Number of study subjects 50 people
- Research Method 1) In patients with advanced hepatocellular carcinoma, peripheral blood will be collected at baseline before treatment, 6 weeks, 12 weeks, 24 weeks, 48 weeks after treatment, and at the time of cancer progression.
- Fresh tumors will be stored in the tissue obtained during the biopsy to perform genetic analysis
Detailed description
This study is designed to perform comprehensive genomic and immune profiling in patients with advanced hepatocellular carcinoma (HCC) undergoing immuno-oncology (IO) treatment. The objective is to investigate molecular and immunologic biomarkers in both blood and tumor tissue that may correlate with treatment response, disease progression, and clinical outcomes.
Eligible patients include those with recurrent, metastatic, or advanced HCC who are scheduled to receive IO therapy and who meet the study's inclusion and exclusion criteria. Approximately 50 participants will be enrolled.
Peripheral blood samples will be collected at predefined time points: prior to initiation of IO treatment (baseline), and at 6, 12, 24, and 48 weeks after treatment initiation, as well as at the time of disease progression. These blood samples will be subjected to genomic and immune profiling, including but not limited to circulating tumor DNA analysis, immune cell subset characterization, and cytokine/chemokine profiling.
In addition, fresh tumor tissue obtained from biopsy procedures will be stored and used for genetic and immunologic analyses. Tissue-based studies may include next-generation sequencing, immunohistochemistry, multiplex immunofluorescence, and other exploratory assays to evaluate tumor mutational landscape, immune checkpoint expression, and tumor microenvironmental features.
By integrating longitudinal blood-based biomarkers with tumor tissue data, this study aims to better characterize tumor biology, immune dynamics, and mechanisms of resistance in advanced HCC treated with immuno-oncology agents. The ultimate goal is to identify predictive and prognostic biomarkers that may guide personalized treatment strategies and improve clinical outcomes in this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed recurrent, locally advanced or metastatic HCC who will receive immuno-oncology treatment
Key inclusion criteria (3 listed)
- Patients with histologically confirmed HCC,
- Patients with histologically confirmed locally advanced, recurrent or metastatic HCC, which was judged not to be eligible for surgical resection, liver transplantation or radiofrequency ablation
- Patients who will receive immuno-oncology treatment
Key exclusion criteria (4 listed)
- Patients with histologically confirmed fibrolamellar type HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Patients with concurrent other malignancy
- Patients who are candidates for local curative treatments such as hepatic resection, liver transplantation, or radiofrequency ablation
- Patients who have a possibility of confusion in the results of the clinical research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective response rate (ORR) according to RECIST 1.1 criteria
Time frame: from the date of the first immunotherapy date', every 9 weeks, for 2 years
Proportion of participants achieving complete response (CR) or partial response (PR) as their best overall response, assessed by imaging according to RECIST 1.1 criteria.
1 secondary outcome
overall survival
Time frame: From date of immunotherapy until the date of death from any cause or study end whichever came first, assessed up to assessed up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ju Hyun Shim principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ju Hyun Shim (0230103190, s5854@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) according to RECIST 1.1 criteria (time frame: from the date of the first immunotherapy date', every 9 weeks, for 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.