Hepato Cellular Carcinoma (HCC)NCT06960863
Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma
An observational study of Hepato Cellular Carcinoma (HCC), run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepato Cellular Carcinoma (HCC)
- What is being tested?
- fibroscan
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbyea, 31516
Dina H Ziada, MD, head of department, 00201117109990, dina.ziada@med.tanta.edu.eg
Rania M Elkafoury, MD
About this study
Official title: Transient Elastography (Fibroscan) for Evaluation of Immunotherapy Response in Hepatocellular Carcinoma.
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.
- Conditions
- Hepato Cellular Carcinoma (HCC)
- Being tested
- fibroscan
- Keywords
- fibroscan, immunotherapy, liver stiffness, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibroscanRadiation
Liver fibrosis and steatosis can be staged using Dimensional ultrasound TE (transient elastography).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Radiation: fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of liver stiffness measurement (kPa)
Measuring liver stiffness (kPa) using Fibroscan before and 6 months after immunotherapy.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Decompensation rate
measuring liver decompensation rate after 6 months of immunotherapy
Measured: through study completion, an average of 1 year
Mortality rate at 6 months follow-up
assessing mortality rate after 6 months of immunotherapy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start26 Jan 2025
- Primary completion15 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mamdouh Elkafoury, Tanta University
- Investigators
- Nabila A Elgazzar, MD, Principal investigator, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960863
- Sponsor's protocol ID
- 36264PR1126/3/25
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transient Elastography (Fibroscan) for Evaluation of Immunotherapy Response in Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT06960863
- Acronym / sponsor ID
- 36264PR1126/3/25
- Conditions
- Hepato Cellular Carcinoma (HCC)
- Keywords
- fibroscan, immunotherapy, liver stiffness, hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 26 Jan 2025 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC patients at baseline | – | Radiation: fibroscanAt 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 |
| HCC patients 6 months post immunotherapy | – | Radiation: fibroscanAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fibroscanLiver fibrosis and steatosis can be staged using Dimensional ultrasound TE (transient elastography). | Radiation | HCC patients 6 months post immunotherapy, HCC patients at baseline |
Primary outcome
Changes of liver stiffness measurement (kPa)
Time frame: through study completion, an average of 1 year
Measuring liver stiffness (kPa) using Fibroscan before and 6 months after immunotherapy.
2 secondary outcomes
Decompensation rate
Time frame: through study completion, an average of 1 year
Mortality rate at 6 months follow-up
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nabila A Elgazzar, MD principal investigator
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepato Cellular Carcinoma (HCC), run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rania M Elkafoury, MD (+201004672358, rania.elkafoury@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of liver stiffness measurement (kPa) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.