NCT06960863Recruiting
Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma
Transient Elastography (Fibroscan) for Evaluation of Immunotherapy Response in Hepatocellular Carcinoma.
Source: ClinicalTrials.gov · Last updated 7 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- 26 Jan 2025
- Primary completion date
- 15 Jan 2026
- Lead sponsor
- Tanta University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06960863
What you commit to
- Study type: Observational
- Planned participants: 80
- From 26 Jan 2025 to the primary completion date, 15 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior locoregional therapy or liver transplantation.
Other illness
- Vascular disorders, arterial hypertension, and risk of variceal bleeding.
- Severe autoimmune disorders.
Other
- Child-Pugh class C patients.
- Patients with performance status \>2 at staging work-up.
- Patients who lost follow-up.
- Pregnant or breastfeeding women.
- Unwilling to participate in our study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta University Hospitals Coordinator of this site? Confirm its status | Tanta | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.