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Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

Recruitingn/aAges 18 Years - anyAllTanta University
NCT06960863 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this prospective cohort study is to evaluate the role of transient elastography (Fibroscan) in predicting the response of immunotherapy in advanced Hepatocellular carcinoma (HCC) patients. Researchers will predict the response to 6 months of HCC immunotherapy regarding improvement of the degree of liver fibrosis, development of liver decompensation, complications, survival, and mortality. Participants will undergo history-taking, clinical examination, laboratory investigations, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, Triphasic CT abdomen with contrast or MRI (for evaluation of tumor site, size and number), and Fibroscan examination at baseline and follow-up after 6 months.

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📋 Eligibility rules (as published)
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.
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What it tests

  • fibroscan
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Where

1 site
Tanta University Hospitals
Tanta, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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