NCT06960863 Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma
| NCT ID | NCT06960863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tanta University |
| Condition | Hepato Cellular Carcinoma (HCC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-01-26 |
| Primary Completion | 2026-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-01-26 with a primary completion date of 2026-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Nabila A Elgazzar, MD
PRINCIPAL INVESTIGATOR
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
Frequently Asked Questions
Who can join the NCT06960863 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepato Cellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06960863 currently recruiting?
Yes, NCT06960863 is actively recruiting participants. Contact the research team at rania.elkafoury@med.tanta.edu.eg for enrollment information.
Where is the NCT06960863 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT06960863 clinical trial?
NCT06960863 is sponsored by Tanta University. The principal investigator is Nabila A Elgazzar, MD at Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University. The trial plans to enroll 80 participants.