Immunogenomic Dynamics and Biomarkers in Patients With Hepatocellular Carcinoma Receiving Immunotherapy

NCT07186010 | Recruiting

• 1 other identifier: KCT0005305
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.Number of study subjects 50 people
4. 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.

Conditions

Hepatocellular Carcinoma; Liver Cancer

Keywords

immunotherapy; biomarker; HCC

Outcome Measures

Primary Outcomes (1)

• 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.

  from the date of the first immunotherapy date', every 9 weeks, for 2 years

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed recurrent, locally advanced or metastatic HCC who will receive immuno-oncology treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Song-pa, 05505, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples containing circulating tumor DNA

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ju Hyun Shim

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ju Hyun Shim

CONTACT

0230103190; s5854@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 22, 2025
• Study Start: September 28, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

KR (1)