Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

Recruiting

• Conditions: Hepato Cellular Carcinoma (HCC)

• Registration Number: NCT06960863
• Lead Sponsor: Tanta University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-26
• Status Verified: 2025-04
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07
• Primary Completion: 2026-01-15
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Decompensation rate	through study completion, an average of 1 year	measuring liver decompensation rate after 6 months of immunotherapy
Mortality rate at 6 months follow-up	through study completion, an average of 1 year	assessing mortality rate after 6 months of immunotherapy

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Gharbyea, Egypt