Hepatocellular CarcinomaT4222NCT05613621
Dissection of the Molecular and Immunological Interaction in Patients With HCC of Viral and Non-viral Etiologies
An observational study of Hepatocellular Carcinoma, run by National Health Research Institutes, Taiwan at 4 sites in Taiwan.
Trial summary
This project will clarify the potential interaction between HBV infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 579 participants
- Where
- 4 sitesTaiwan
- Study dates
- 14 Aug 2025to 31 Dec 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hepatocellular carcinoma patients
Who may be able to join
- Adult female or male patients aged ≥20 years.
- HCC has been histologically confirmed with resection specimen.
- The surgery should be performed with curative intent after 2015 in the study hospital.
- Availability of serum HBsAg and Anti-HBc data in the electronic medical record.
- Availability of imaging data performed within 3 months before the surgery in the electronic medical record. (at least one of the following: computed tomography, magnetic resonance imaging, abdominal sonography).
- Informed consent is obtained. Willingness to provide the residual operative slides and medical records.
Who cannot join
- Fibrolamellar HCC, sarcomatoid HCC, or a mixture of cholangiocarcinoma and HCC
- Exclusion of HCV patients (Anti-HCV positive)
- Inability to cooperate by providing a complete medical history.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
National Cheng-Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei, 100
Mackay Memorial Hospital
Taipei
National Taiwan University Cancer Center
Taipei
About this study
Official title: Dissection of the Molecular and Immunological Interaction in Patients With Hepatocellular Carcinoma of Viral and Non-viral Etiologies
This project will clarify the potential interaction between HBV infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.
Read the detailed description
This study will start with a "training cohort" of the NTUH and NTU Cancer Center patients, consisting of 4 sub-groups: HBV (+) steatosis (+), HBV (-) steatosis (+), HBV (+) steatosis (-) and HBV (-) steatosis (-). HBV (+) is defined as either: (a) HBsAg (+) or (b) HBsAg (-) anti-HBc (+) and HBV DNA detectable in blood or tumor tissue. Steatosis is defined by histology. We will enroll 400 patients who had sufficient tissue for testing in the training cohort. The following studies will be performed: (1) NGS of targeted genes panel using the National Health Research Institutes precision medicine platform; (2) transcriptomic analysis of immune microenvironment using RNA-seq and multiplex immunofluorescence staining; (3) lipotoxic genotyping for SNPs; (4) clinical outcomes of MAFLD vs. non-MAFLD. The genetic and immunological features will be further tested by a "validation cohort", from collaborative hospitals. This project will clarify the potential interaction between HBV infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, next-generation sequencing, precision medicine
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| training cohort | Consisting of 4 sub-groups: HBV (+) steatosis (+), HBV (-) steatosis (+), HBV (+) steatosis (-) and HBV (-) steatosis (-). HBV (+) is defined as either: (a) HBsAg (+) or (b) HBsAg (-) anti-HBc (+) and HBV DNA detectable in blood or tumor tissue. Steatosis is defined by histology. We will enroll 400 patients who had sufficient tissue for testing in the training cohort. | |
| validation cohort | For the validation cohort, the clinical and pathological information will be obtained retrospectively by TCOG and will take 6 months to identify eligible patients for the 4 sub-groups listed above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
transcriptomic analysis of immune microenvironment
using RNA-seq and multiplex immunofluorescence staining
Measured: 2 Years
lipotoxic genotyping for SNPs
lipotoxic genotyping for SNPs
Measured: 2 years
clinical outcomes of MAFLD vs. non-MAFLD.
clinical outcomes of MAFLD vs. non-MAFLD.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start14 Aug 2025
- 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.
- 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
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital
- Responsible party
- Sponsor
- Investigators
- Tsang-Wu Liu, Study director, Taiwan Cooperative Oncology Group, NHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613621
- Sponsor's protocol ID
- T4222
- Acronym
- T4222
- Status last verified
- Aug 2025
- First submitted
- 1 Nov 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissection of the Molecular and Immunological Interaction in Patients With Hepatocellular Carcinoma of Viral and Non-viral Etiologies
- ClinicalTrials.gov ID
- NCT05613621
- Acronym / sponsor ID
- T4222 / T4222
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, next-generation sequencing, precision medicine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 579 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Nov 2022 (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.
This project will clarify the potential interaction between HBV infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.
Detailed description
This study will start with a "training cohort" of the NTUH and NTU Cancer Center patients, consisting of 4 sub-groups: HBV (+) steatosis (+), HBV (-) steatosis (+), HBV (+) steatosis (-) and HBV (-) steatosis (-). HBV (+) is defined as either: (a) HBsAg (+) or (b) HBsAg (-) anti-HBc (+) and HBV DNA detectable in blood or tumor tissue. Steatosis is defined by histology. We will enroll 400 patients who had sufficient tissue for testing in the training cohort. The following studies will be performed: (1) NGS of targeted genes panel using the National Health Research Institutes precision medicine platform; (2) transcriptomic analysis of immune microenvironment using RNA-seq and multiplex immunofluorescence staining; (3) lipotoxic genotyping for SNPs; (4) clinical outcomes of MAFLD vs. non-MAFLD. The genetic and immunological features will be further tested by a "validation cohort", from collaborative hospitals. This project will clarify the potential interaction between HBV infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training cohort | – | –Consisting of 4 sub-groups: HBV (+) steatosis (+), HBV (-) steatosis (+), HBV (+) steatosis (-) and HBV (-) steatosis (-). HBV (+) is defined as either: (a) HBsAg (+) or (b) HBsAg (-) anti-HBc (+) and HBV DNA detectable in blood or tumor tissue. Steatosis is defined by histology. We will enroll 400 patients who had sufficient tissue for testing in the training cohort. |
| validation cohort | – | –For the validation cohort, the clinical and pathological information will be obtained retrospectively by TCOG and will take 6 months to identify eligible patients for the 4 sub-groups listed above. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hepatocellular carcinoma patients
Key inclusion criteria (6 listed)
- Adult female or male patients aged ≥20 years.
- HCC has been histologically confirmed with resection specimen.
- The surgery should be performed with curative intent after 2015 in the study hospital.
- Availability of serum HBsAg and Anti-HBc data in the electronic medical record.
- Availability of imaging data performed within 3 months before the surgery in the electronic medical record. (at least one of the following: computed tomography, magnetic resonance imaging, abdominal sonography).
Key exclusion criteria (3 listed)
- Fibrolamellar HCC, sarcomatoid HCC, or a mixture of cholangiocarcinoma and HCC
- Exclusion of HCV patients (Anti-HCV positive)
- Inability to cooperate by providing a complete medical history.
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
transcriptomic analysis of immune microenvironment
Time frame: 2 Years
using RNA-seq and multiplex immunofluorescence staining
lipotoxic genotyping for SNPs
Time frame: 2 years
lipotoxic genotyping for SNPs
clinical outcomes of MAFLD vs. non-MAFLD.
Time frame: 2 years
clinical outcomes of MAFLD vs. non-MAFLD.
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 15 Aug 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. This study is not recruiting at the moment.
Tsang-Wu Liu study director
Taiwan Cooperative Oncology Group, NHRI
4 sites 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, run by National Health Research Institutes, Taiwan at 4 sites in Taiwan.
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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transcriptomic analysis of immune microenvironment (time frame: 2 Years). The study lists 3 primary outcomes in all. 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 15 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.