Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

Tanta University80 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepato Cellular Carcinoma (HCC)

Interventions

fibroscanRADIATION

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

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 year

Secondary Outcomes

Decompensation rate

measuring liver decompensation rate after 6 months of immunotherapy

Time frame: through study completion, an average of 1 year

Mortality rate at 6 months follow-up

assessing mortality rate after 6 months of immunotherapy

Time frame: through study completion, an average of 1 year

Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts