Actively Recruiting
Transient Elastography (Fibroscan) for Evaluation of Immunotherapy Response in Hepatocellular Carcinoma
Led by Tanta University · Updated on 2025-05-07
80
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of transient elastography (Fibroscan) to predict how patients with advanced Hepatocellular Carcinoma (HCC) respond to immunotherapy. The study aims to assess changes in liver fibrosis, liver decompensation, complications, survival, and mortality over a 6-month treatment period. This observational study focuses on patients with advanced HCC who are eligible for immunotherapy and have preserved liver function. Participants will undergo a range of assessments at the start of the study, including medical history, clinical exams, lab tests, liver function classifications (Child-Pugh and MELD scores), cancer staging (BCLC), abdominal ultrasound, imaging studies (Triphasic CT or MRI), and Fibroscan to measure liver stiffness. After 6 months of immunotherapy, patients will return for follow-up visits involving laboratory tests, evaluation of treatment side effects, imaging, and another Fibroscan exam to monitor changes. During the study, researchers will track liver stiffness changes as the primary outcome over about one year. Secondary outcomes include rates of liver decompensation and mortality at 6 months. Participants will be monitored through clinic visits, imaging, and laboratory evaluations to assess their response to immunotherapy and overall health status. The total participation duration includes baseline assessments and a 6-month follow-up period.
CONDITIONS
Brief Title
Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed advanced HCC diagnosed by two imaging methods or liver biopsy and eligible for immunotherapy
- Patients with preserved liver function classified as compensated Child-Pugh A if cirrhosis is present
- Patients with a performance status of 2 or less at staging
- No high-risk bleeding signs on upper endoscopy, including properly treated oesophageal varices and no history of variceal bleeding to reduce bleeding risk
You will not qualify if you...
- Prior locoregional therapy or liver transplantation
- Patients with Child-Pugh class C liver function
- Patients with performance status greater than 2 at staging
- Presence of vascular disorders, arterial hypertension, or high risk of variceal bleeding
- Severe autoimmune disorders
- Patients lost to follow-up
- Pregnant or breastfeeding women
- Patients unwilling to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo history-taking, clinical examination, laboratory investigations, liver function assessments, imaging studies including abdominal ultrasound, CT or MRI, and Fibroscan examination to evaluate liver stiffness and tumor characteristics.
1 visit (in-person)
Duration - Up to 1 year
Participants are followed up for approximately 6 months to 1 year with clinic visits including laboratory tests, evaluation of treatment-related side effects, imaging studies, and Fibroscan examinations to monitor changes in liver stiffness and clinical outcomes.
1 visit at 6 months follow-up
Trial Site Locations
Total: 1 location
1
Tanta University Hospitals
Tanta, Gharbyea, Egypt, 31516
Actively Recruiting
Research Team
R
Rania M Elkafoury, MD
N
Nabila A Elgazzar, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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