Immunogenomic Dynamics and Biomarkers in Patients With Hepatocellular Carcinoma Receiving Immunotherapy

Recruiting

• Conditions: Hepatocellular Carcinoma; Liver Cancer

• Registration Number: NCT07186010
• Lead Sponsor: Asan Medical Center

Brief 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. 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.

3. Number of study subjects 50 people

4. 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.

2\) 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 Timeline

• Study Start: 2020-09-28
• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients with histologically confirmed HCC,
2. 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
3. Patients who will receive immuno-oncology treatment

Exclusion Criteria

1. Patients with histologically confirmed fibrolamellar type HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
2. Patients with concurrent other malignancy
3. Patients who are candidates for local curative treatments such as hepatic resection, liver transplantation, or radiofrequency ablation
4. Patients who have a possibility of confusion in the results of the clinical research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) according to RECIST 1.1 criteria	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.

Secondary Outcome Measures

Name	Time	Method
overall survival	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	overall survival after initiation of immunotherapy

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Song-pa, South Korea