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Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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.

Study details
    Hepato Cellular Carcinoma (HCC)

NCT06960863

Tanta University

13 May 2025

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