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RecruitingNCT06960863Updated May 7, 2025

Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma

An observational study in Hepato Cellular Carcinoma (HCC), sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-07.

Sponsored by Tanta University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hepato Cellular Carcinoma (HCC)

Keywords

  • fibroscan
  • immunotherapy
  • liver stiffness
  • hepatocellular carcinoma
03

In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 80 is below the median of 200 across 769 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Tanta University is the lead sponsor of 987 studies on the registry; 313 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Tanta University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This prospective cohort study will be carried out on 80 patients attending to Tanta tropical medicine outpatient clinic, faculty of medicine. The start of the research will be in January 2025 to January 2026 or until collecting the cases.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • HCC patients at baseline

    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

    Radiation: fibroscan

  • HCC patients 6 months post immunotherapy

    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.

    Radiation: fibroscan

Interventions

  • Radiationfibroscan

    Liver fibrosis and steatosis can be staged using Dimensional ultrasound TE (transient elastography).

06

What researchers measure

Primary outcomes

  1. Changes of liver stiffness measurement (kPa)

    Measuring liver stiffness (kPa) using Fibroscan before and 6 months after immunotherapy.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Decompensation rate

    measuring liver decompensation rate after 6 months of immunotherapy

    Time frame: through study completion, an average of 1 year

  2. Mortality rate at 6 months follow-up

    assessing mortality rate after 6 months of immunotherapy

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Tanta University Hospitals
    Tanta, Gharbyea 31516, Egypt
    • Dina H Ziada, MD, head of department · Contact · dina.ziada@med.tanta.edu.eg · 00201117109990
    • Rania M Elkafoury, MD · Sub investigator
    • Nabila A Elgazzar, MD · Principal investigator
    • Madonna M Fahmy, MD · Sub investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Jan 2026, 11 months after the start.

Of 273 non-industry observational studies under Carcinoma, Hepatocellular, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 112. This study's planned 11 months is below that.

Counting every sponsor, half of 313 studies reached it within 50 months; a quarter within 32 and three quarters within 98.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2025
First posted
May 7, 2025
StartActual
Jan 26, 2025
Primary completionEst.
Jan 15, 2026
CompletionEst.
Jan 31, 2026
Last update
May 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06960863
Lead sponsor
Tanta University
Responsible party
Rania Mamdouh Elkafoury (lecturer of Tropical medicine, Tanta University) — Principal investigator
First posted
May 7, 2025
Start date
Jan 26, 2025
Primary completion
Jan 15, 2026 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
May 7, 2025

Study contacts

Rania M Elkafoury, MD
Contact
rania.elkafoury@med.tanta.edu.eg
+201004672358
Nabila A Elgazzar, MD
Contact
nabilaelgazzar@med.tanta.edu.eg
00201288585733
Nabila A Elgazzar, MD
principal investigator · Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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