Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma
ConditionHepato Cellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTanta University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
fibroscan
RadiationLiver fibrosis and steatosis can be staged using Dimensional ultrasound TE (transient elastography).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: HCC patients at baseline1 intervention
Group B: HCC patients 6 months post immunotherapy1 intervention
Trial outcomes
Primary outcomes
1
Changes of liver stiffness measurement (kPa)
Measuring liver stiffness (kPa) using Fibroscan before and 6 months after immunotherapy.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Decompensation rate
measuring liver decompensation rate after 6 months of immunotherapy
Time frame
through study completion, an average of 1 year2
Mortality rate at 6 months follow-up
assessing mortality rate after 6 months of immunotherapy
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov