Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

NCT ID: NCT06960863

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-26
• Study Completion Date: 2026-01-31

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

fibroscan

Intervention Type: RADIATION

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

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.

fibroscan

Intervention Type: RADIATION

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

Interventions

fibroscan

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

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Rania Mamdouh Elkafoury

lecturer of Tropical medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nabila A Elgazzar, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Tanta University Hospitals

Tanta, Gharbyea, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Rania M Elkafoury, MD

Role: CONTACT

rania.elkafoury@med.tanta.edu.eg

+201004672358

Nabila A Elgazzar, MD

Role: CONTACT

nabilaelgazzar@med.tanta.edu.eg

00201288585733

Facility Contacts

Dina H Ziada, MD, head of department

Role: primary

dina.ziada@med.tanta.edu.eg

00201117109990

Other Identifiers

36264PR1126/3/25

Identifier Type: -

Identifier Source: org_study_id