Clinical trial · Observational
Immunogenomic Dynamics and Biomarkers in Patients With Hepatocellular Carcinoma Receiving Immunotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate (ORR) according to RECIST 1.1 criteria
- timeFrame
- from the date of the first immunotherapy date', every 9 weeks, for 2 years
- description
- 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 outcomes (1)
- measure
- overall survival
- timeFrame
- 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
- description
- overall survival after initiation of immunotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available