RecruitingNCT06960863

Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

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

Sponsor

Tanta University

Enrollment

80 participants

Start Date

Jan 26, 2025

Study Type

OBSERVATIONAL

Conditions

Hepato Cellular Carcinoma (HCC)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria8

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.

Interventions

RADIATIONfibroscan

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

Locations(1)

Tanta University Hospitals

Tanta, Gharbyea, Egypt

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