Clinical trial NCT06960863: Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma
Official title: Transient Elastography (Fibroscan) for Evaluation of Immunotherapy Response in Hepatocellular Carcinoma.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepato Cellular Carcinoma (HCC)
Keywords: fibroscan
immunotherapy
liver stiffness
hepatocellular carcinoma
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Changes of liver stiffness measurement (kPa)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Decompensation rate
timeFrame: through study completion, an average of 1 year
measure: Mortality rate at 6 months follow-up
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbyea
Study officials:
affiliation: Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
name: Nabila A Elgazzar, MD
role: PRINCIPAL_INVESTIGATOR
References: