Actively Recruiting

Age: 18Years +
All Genders
NCT06960863

Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

Led by Tanta University · Updated on 2025-05-07

80

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with confirmed advanced HCC diagnosed by two imaging methods or liver biopsy who are eligible for immunotherapy
  • Preserved liver function with compensated Child-Pugh A if cirrhosis is present
  • Performance status of 2 or less at staging
  • No high-risk signs for bleeding on upper endoscopy, such as treated oesophageal varices and no history of variceal bleeding
Not Eligible

You will not qualify if you...

  • Previous locoregional therapy or liver transplantation
  • Child-Pugh class C liver function
  • Performance status greater than 2 at staging
  • Presence of vascular disorders, arterial hypertension, or risk of variceal bleeding
  • Severe autoimmune disorders
  • Lost to follow-up
  • Pregnant or breastfeeding women
  • Unwillingness to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tanta University Hospitals

Tanta, Gharbyea, Egypt, 31516

Actively Recruiting

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Research Team

R

Rania M Elkafoury, MD

CONTACT

N

Nabila A Elgazzar, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma | DecenTrialz