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NCT Number: NCT06960863

Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

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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Key information

Conditions

Hepato Cellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Location status: Recruiting

Location contact

Dina H Ziada, MD, head of department

CONTACT

[email protected]

00201117109990

Madonna M Fahmy, MD

SUB_INVESTIGATOR

Nabila A Elgazzar, MD

PRINCIPAL_INVESTIGATOR

Rania M Elkafoury, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fibroscan

Radiation

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

Primary outcomes

  1. Changes of liver stiffness measurement (kPa)

    Time frame: through study completion, an average of 1 year

    Measuring liver stiffness (kPa) using Fibroscan before and 6 months after immunotherapy.

Secondary outcomes

  1. Decompensation rate

    Time frame: through study completion, an average of 1 year

    measuring liver decompensation rate after 6 months of immunotherapy

  2. Mortality rate at 6 months follow-up

    Time frame: through study completion, an average of 1 year

    assessing mortality rate after 6 months of immunotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Nabila A Elgazzar, MD

CONTACT

[email protected]

00201288585733

Rania M Elkafoury, MD

CONTACT

[email protected]

+201004672358

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Transient Elastography (Fibroscan) for Evaluation of Immunotherapy Response in Hepatocellular Carcinoma.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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