Hepato Cellular Carcinoma (HCC)
Conditions
Keywords
fibroscan, immunotherapy, liver stiffness, hepatocellular carcinoma
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.
Interventions
RADIATIONfibroscan
Liver fibrosis and steatosis can be staged using Dimensional ultrasound TE (transient elastography).
Sponsors
Tanta University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of liver stiffness measurement (kPa) | through study completion, an average of 1 year | Measuring liver stiffness (kPa) using Fibroscan before and 6 months after immunotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decompensation rate | through study completion, an average of 1 year | measuring liver decompensation rate after 6 months of immunotherapy |
| Mortality rate at 6 months follow-up | through study completion, an average of 1 year | assessing mortality rate after 6 months of immunotherapy |
Countries
Egypt
Contacts
Primary ContactRania M Elkafoury, MD
Backup ContactNabila A Elgazzar, MD
Outcome results
None listed