Evaluating liver stiffness to predict immunotherapy response in liver cancer
Transient Elastography (Fibroscan) for Evaluation of Immunotherapy Response in Hepatocellular Carcinoma.
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 |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Tanta, Gharbyea) |
| Trial ID | NCT06960863 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed advanced HCC who are eligible for immunotherapy and have preserved liver function.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tanta, Gharbyea
- 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
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.