Tracking immune and genomic changes in liver cancer during immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.