Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

Tanta University

Status: Enrolling

Conditions: Hepato Cellular Carcinoma (HCC)

Treatments: Radiation: fibroscan

Study type: Observational

Funder types: Other

Identifiers

NCT06960863

36264PR1126/3/25

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 2 patient groups

HCC patients at baseline

Description:

At baseline, patients 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

Treatment:

Radiation: fibroscan

HCC patients 6 months post immunotherapy

Description:

All patients will be followed up after 6 months with clinic visits including laboratory testing, evaluation of treatment-related side effects, imaging studies, and fibroscan examination.

Treatment:

Radiation: fibroscan