Discovering tumor antigens for innovative cancer treatments in liver cancer
Official title: Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: from Benchside to Bedside (HepAnt) - Study of the Role of the Metagenome in Head and Neck Tumors Using Omics Techniques - HeNomics
Run by National Cancer Institute, Naples · NCT06905262 · Data updated 2026-11-12
This study is trying to find new cancer treatments for liver cancer by looking at the gut bacteria in patients and seeing how it compares to healthy people and those with other cancers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 1 site (Naples) |
| Status | Recruiting |
| Started | January 2, 2023 |
| Main results expected | September 30, 2025 |
| Study ends | September 30, 2025 |
| Registry record updated | April 1, 2025 |
| Trial ID | NCT06905262 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a histological diagnosis of primary hepatocellular carcinoma or other oncological conditions.
✕Probably not a fit
Patients without a diagnosis of hepatocellular carcinoma or other oncological pathologies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to analyze the microbiota and microbiome in patients with hepatocellular carcinoma (HCC) and compare it with healthy subjects and those with other oncological pathologies. It utilizes omics techniques to evaluate the intestinal, salivary, and intratumoral microbiomes, focusing on multiple taxonomic levels. Additionally, the study seeks to identify tumor antigens that share sequence homology with peptides derived from the microbiota through bioinformatic analysis.
Why it matters
Potential benefit: If successful, this research could lead to the development of innovative immunotherapies for patients with liver cancer.
How similar studies have gone: While this approach is innovative, similar studies exploring the relationship between microbiomes and cancer have shown promising results, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological diagnosis of primary HCC and other oncological pathology (Pascale Institute) or diagnosis of oncological pathology (without any exclusions) from an accredited medical-clinical facility (Fortore Mountain Community). * Age ≥18 years * Ability to give signed informed consent that includes compliance with the requirements and constraints listed in the informed consent form (ICF) and in this protocol. * In the case of paraffin-embedded samples obtained from the UOC of Pathological Anatomy and/or the Institute's Biological Bank, informed consent cannot be acquired, in accordance with the Provision of the Privacy Authority containing the requirements relating to the processing of special categories of data, pursuant to art. 21, paragraph 1 of Legislative Decree 10 August 2018, no. 101, published in the Official Journal - general series - no. 176 of 29/07/2019, point 5 "Provisions relating to the processing of personal data carried out for scientific research purposes (gen. aut. n. 9/2016)" HEALTHY SUBJECTS * clinical history free from diagnosis of tumor or neoplastic pathology treated during life * Age ≥80 years * Ability to give signed informed consent that includes compliance with the requirements and constraints listed in the informed consent form (ICF) and in this protocol Exclusion Criteria: * Current pathologies requiring antibiotic therapy * Diagnosis of pre-tumor pathology (in healthy subjects)
Where it's running
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Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Naples, Italy Recruiting
Study contacts
- Principal investigator: Luigi Buonaguro — IRCCS I.N.T. "G. Pascale"
- Study coordinator: Luigi Buonaguro, DR
- Email: l.buonaguro@istitutotumori.na.it
- Phone: 08117770587
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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InstaSure Non-Invasive Finger-Press Test for HCC
This study tests a non-invasive finger-skin test to help identify hepatocellular carcinoma in adults.
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BGB-B2033 vs Sorafenib or Lenvatinib for advanced liver cancer
This study tests whether the investigational drug BGB-B2033 can help people with advanced hepatocellular carcinoma when given after prior PD-1/PD-L1 therapy, compared with the standard medicines sorafenib or lenvatinib.
-
Zinc add-on with targeted therapy plus immunotherapy for advanced liver cancer
This study tests whether adding daily zinc to standard targeted therapy and immunotherapy helps people with unresectable or advanced hepatocellular carcinoma.
-
68Ga-SorB PET/CT imaging for solid tumors
This study tests a new PET tracer called 68Ga-SorB to see if it can safely and accurately detect tumors in adults with melanoma, liver, lung, breast, pancreatic, ovarian cancer, or cholangiocarcinoma.
-
Hepatocellular Carcinoma Patient Registry (CHARM Hepatocellular Carcinoma MEA)
This observational study collects medical records of adults with hepatocellular carcinoma to understand how the disease presents and progresses across regions in the Middle East and North Africa.
-
GLP-1 RA plus standard treatment in first-line metastatic GI cancers
This early-phase trial tests whether adding a GLP-1 receptor agonist to standard first-line chemotherapy is safe and feasible for people with metastatic pancreatic, colorectal, or liver cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.