Evaluating liver stiffness to predict immunotherapy response in liver cancer
Official title: Transient Elastography (Fibroscan) for Evaluation of Immunotherapy Response in Hepatocellular Carcinoma.
Run by Tanta University · NCT06960863 · Data updated 2026-11-12
This study is testing if a special scan can help predict how well people with advanced liver cancer will respond to immunotherapy treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Tanta University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Tanta, Gharbyea) |
| Status | Recruiting |
| Started | January 26, 2025 |
| Main results expected | January 15, 2026 |
| Study ends | January 31, 2026 |
| Registry record updated | May 7, 2025 |
| Trial ID | NCT06960863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with confirmed advanced HCC who are eligible for immunotherapy and have preserved liver function.
✕Probably not a fit
Patients with severe liver dysfunction, prior locoregional therapy, or those with a performance status greater than 2 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 observational study aims to assess the effectiveness of transient elastography, known as Fibroscan, in predicting how patients with advanced Hepatocellular carcinoma (HCC) respond to immunotherapy over a six-month period. Participants will undergo a series of evaluations, including clinical examinations, laboratory tests, and imaging studies, to monitor liver fibrosis and other health indicators. The study will track changes in liver condition, complications, and overall survival rates to determine the predictive value of Fibroscan in this context.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to better predict treatment responses in patients with advanced liver cancer.
How similar studies have gone: While the use of Fibroscan in this specific context is novel, similar studies have shown promise in using non-invasive methods to assess liver conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with confirmed advanced HCC (Diagnosed by two imaging modalities or liver biopsy) eligible for immunotherapy. * Patients with preserved liver function (compensated Child-Pugh A if there is underlying cirrhosis). * Patients with performance status ≤2 at staging work-up. * absence of high-risk stigmata for bleeding on upper endoscopy, e.g. properly treated oesophageal varices and no history of variceal bleeding, in order to minimise bleeding risk. Exclusion Criteria: * Prior locoregional therapy or liver transplantation. * Child-Pugh class C patients. * Patients with performance status \>2 at staging work-up. * Vascular disorders, arterial hypertension, and risk of variceal bleeding. * Severe autoimmune disorders. * Patients who lost follow-up. * Pregnant or breastfeeding women. * Unwilling to participate in our study.
Where it's running
-
Tanta University Hospitals
Tanta, Gharbyea, Egypt Recruiting
Study contacts
- Principal investigator: Nabila A Elgazzar, MD — Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
- Study coordinator: Rania M Elkafoury, MD
- Email: rania.elkafoury@med.tanta.edu.eg
- Phone: +201004672358
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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.