Dissection of the Molecular and Immunological Interaction in Patients With HCC of Viral and Non-viral Etiologies

NCT ID: NCT05613621

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 579 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-14
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Adult female or male patients aged ≥20 years.

2. HCC has been histologically confirmed with resection specimen.

3. The surgery should be performed with curative intent after 2015 in the study hospital.

4. Availability of serum HBsAg and Anti-HBc data in the electronic medical record.

5. 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).

6. Informed consent is obtained. Willingness to provide the residual operative slides and medical records.

Exclusion Criteria

1. Fibrolamellar HCC, sarcomatoid HCC, or a mixture of cholangiocarcinoma and HCC

2. Exclusion of HCV patients (Anti-HCV positive)

3. Inability to cooperate by providing a complete medical history.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsang-Wu Liu

Role: STUDY_DIRECTOR

Taiwan Cooperative Oncology Group, NHRI

Locations

National Cheng-Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

National Taiwan University Cancer Center

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

T4222

Identifier Type: -

Identifier Source: org_study_id