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
Qualifiers
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 design
Treatments tested in this trial
- fibroscan
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov