Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fibroscan.
- Who it may be relevant to
- Registry conditions: Hepato Cellular Carcinoma (HCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transient Elastography (Fibroscan) for Evaluation of Immunotherapy Response in Hepatocellular Carcinoma.
Overview
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.
Interventions
- Radiation fibroscan
Liver fibrosis and steatosis can be staged using Dimensional ultrasound TE (transient elastography).
Primary outcome measures
- Changes of liver stiffness measurement (kPa) [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
- Decompensation rate [Time frame: through study completion, an average of 1 year]
- Mortality rate at 6 months follow-up [Time frame: through study completion, an average of 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Tanta University Hospitals — Tanta
Identifiers
NCT: NCT06960863 · 36264PR1126/3/25