Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

NCT06960863 · tracked via the Priya Life Science Egypt tracker

Sponsor

Tanta University

Phase

Observational

Started

2025-01-26

Last updated

2025-05-07

Condition(s) studied

Hepato Cellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

fibroscan

fibroscan: Liver fibrosis and steatosis can be staged using Dimensional ultrasound TE (transient elastography).

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Changes of liver stiffness measurement (kPa) — through study completion, an average of 1 year
Measuring liver stiffness (kPa) using Fibroscan before and 6 months after immunotherapy.

Trial sites (1)

Facility	City	Region	Status
Tanta University Hospitals	Tanta	Gharbyea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06960863 on ClinicalTrials.gov ↗ ← All trials in Egypt