Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

NCT06960863 | Recruiting

• 1 other identifier: 36264PR1126/3/25
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepato Cellular Carcinoma (HCC)

Keywords

fibroscan; immunotherapy; liver stiffness; hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Changes of liver stiffness measurement (kPa)

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

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Decompensation rate

  through study completion, an average of 1 year

• Mortality rate at 6 months follow-up

  through study completion, an average of 1 year

Study Arms (2)

HCC patients at baseline

At baseline, patients 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

Radiation: fibroscan

HCC patients 6 months post immunotherapy

All patients will be followed up after 6 months with clinic visits including laboratory testing, evaluation of treatment-related side effects, imaging studies, and fibroscan examination.

Radiation: fibroscan

Interventions

fibroscan RADIATION

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

HCC patients 6 months post immunotherapy; HCC patients at baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective cohort study will be carried out on 80 patients attending to Tanta tropical medicine outpatient clinic, faculty of medicine. The start of the research will be in January 2025 to January 2026 or until collecting the cases.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Nabila A Elgazzar, MD

  Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rania M Elkafoury, MD

CONTACT

+201004672358; rania.elkafoury@med.tanta.edu.eg

Nabila A Elgazzar, MD

CONTACT

00201288585733; nabilaelgazzar@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Tropical medicine

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: January 26, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 31, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

EG (1)