Tracking immune and genomic changes in liver cancer during immunotherapy
Immunogenomic Dynamics and Biomarkers in Patients With Hepatocellular Carcinoma Receiving Immunotherapy
This study will test whether blood and tumor biomarkers can predict how people with advanced hepatocellular carcinoma respond to immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul, Song-pa) |
| Trial ID | NCT07186010 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort of about 50 patients with recurrent, locally advanced, or metastatic hepatocellular carcinoma who are receiving immuno-oncology treatment. Researchers will collect peripheral blood at baseline, 6, 12, 24, and 48 weeks after treatment start and at disease progression, and will store fresh tumor tissue obtained by biopsy for molecular and immune analyses. Blood-based assays may include circulating tumor DNA, immune cell subset profiling, and cytokine measurements, while tissue studies may include next-generation sequencing, immunohistochemistry, and multiplex immunofluorescence. Longitudinal integration of blood and tissue data will be used to correlate molecular and immunologic features with treatment response and clinical outcomes.
Who should consider this trial
Good fit: Adults with histologically confirmed recurrent, locally advanced, or metastatic hepatocellular carcinoma who are scheduled to receive immuno-oncology therapy and meet the study's inclusion and exclusion criteria.
Not a fit: Patients with fibrolamellar or sarcomatoid HCC, mixed cholangiocarcinoma–HCC, concurrent other malignancies, or those eligible for curative local therapies are excluded and are unlikely to benefit from this study's results.
Why it matters
Potential benefit: If successful, the findings could help clinicians use blood or tumor tests to predict who will benefit from immunotherapy and personalize care.
How similar studies have performed: Prior studies in HCC and other cancers have shown promising signals that circulating tumor DNA and immune profiling can predict immunotherapy response, but findings are variable and require further validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul, Song-pa
- Asan Medical Center — Seoul, Song-pa, South Korea (Recruiting)
Study contacts
- Principal investigator: Ju Hyun Shim — Asan Medical Center
- Study coordinator: Ju Hyun Shim
- Email: s5854@amc.seoul.kr
- Phone: 0230103190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.