HCC - Hepatocellular CarcinomaHCCNCT07814014
Real-world Insight Into Systemic Therapies for HCC: Single-center Study
An observational study of HCC - Hepatocellular Carcinoma, run by Mansoura University at 1 site in Egypt.
Trial summary
Real-world data from a single-center experience evaluating patients with hepatocellular carcinoma (HCC) receiving systemic therapies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 15 Dec 2027
- 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: Patients with HCC that are recruited to the tropical medicine inpatient department and outpatient clinics and are submitted to the inclusion and exclusion criteria from June 2022 to November 2024.
Who may be able to join
- patient with HCC
- Child-Pugh class A, B7
- Performance state 0-1 (Eastern Cooperative Oncology Group (ECOG scale).
- Barcelona Clinic Liver Cancer (BCLC) stage C or BCLC stage B with diffuse, infiltrative or extensive bilobar involvement or BCLC stage B with tumor progression after TACE.
Who cannot join
- patient with other tumor than HCC
- Child-Turcotte-Pugh score B (8,9) and C.
- Patients eligible for treatment other than systemic therapy according to Barcelona Clinic liver cancer.
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
Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35516
Mahmoud M El-Bendary, +201002592205, mmelbendary@gmail.com
Mahmoud M El-Bendary, MD
About this study
Official title: Real-world Insight Into Systemic Therapies for Hepatocellular Carcinoma: a Comprehensive Single-center Study
Real-world data from a single-center experience evaluating patients with hepatocellular carcinoma (HCC) receiving systemic therapies
Read the detailed description
This retrospective cohort study will be conducted at the Tropical Medicine Department of Mansoura University Hospitals, recruiting patients with advanced hepatocellular carcinoma (HCC) who will receive systemic therapy between June 2022 and November 2024. Eligible participants will include those with Child-Pugh class A liver function, ECOG performance status 0-1, and Barcelona Clinic Liver Cancer (BCLC) stage C, or stage B with diffuse, infiltrative, or extensive bilobar involvement, or progression after transarterial chemoembolization (TACE). Additional laboratory and clinical criteria will be required, such as adequate blood counts, liver and renal function, and absence of large or risky esophageal varices. Patients with Child-Pugh class B or C, early or terminal stage disease, or contraindications to systemic therapy such as active infections, autoimmune conditions, or severe comorbidities will be excluded.
Operationally, all patients will undergo comprehensive history taking, physical examination, radiological imaging (ultrasound, triphasic CT, or MRI), and laboratory testing, including liver function, renal function, virology markers, and tumor biomarkers such as alpha-fetoprotein (AFP). Follow-up assessments will be performed every three months using physical exams, imaging, and laboratory tests to monitor disease progression and treatment outcomes. Data will be systematically collected and analyzed using SPSS version 25, with qualitative variables expressed as frequencies and percentages, and quantitative data assessed for normality and described accordingly. Statistical tests such as Chi-square and correlation analyses will be applied to evaluate associations, with the ultimate aim of estimating progression-free survival and overall survival in this patient population.
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCC patients on systemic therapies | 1. HCC patients receiving TKI (Sorafenib and Regrofenib 2. HCC patients receiving Atezolizumab with Bevacizumab 3. HCC patients receiving Tremelimumab with Durvalumab 4 -HCC patients With positive PCR HCV treating by DAAs with systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
time from initiation of systemic therapy to death from any cause
Measured: 1 year
treatment response
m-RESIST analysis of the patients as its categories
- CR - Complete response Disappearance of all arterial enhancement in all target lesions
- PR - Partial response ≥30% decrease in the sum of diameters of viable tumor
- SD - Stable disease Neither sufficient decrease for PR nor sufficient increase for PD
- PD - Progressive disease ≥20% increase in the sum of viable tumor diameters, with an absolute increase of ≥5 mm, or appearance of new lesions/other progression criteria
Measured: 1 year
progression free survival (PFS)
time from initiation of systemic therapy to radiological diseasas progression or death from any cause , whichever occur first
Measured: one year
Secondary outcomes (1)
efficacy of DAAs in treatment of HCV in patients with active HCV infection and HCC during receiving systemic therapy
treatment of HCV infection in patient with HCC and active HCV infection during receiving systemic therapy of HCC which will be assed by PCR done 12 w after the end of treatment ,
- SVR: HCV RNA remains undetectable 12 weeks after completing treatment. This is the standard definition of virologic cure.
- Or non responder as HCV RNA is still detected after 12 w of complete treatment -how it will affect liver function
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Aug 2026
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Elbendary, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814014
- Sponsor's protocol ID
- MS.24.11.2985
- Acronym
- HCC
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be shared after reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Insight Into Systemic Therapies for Hepatocellular Carcinoma: a Comprehensive Single-center Study
- ClinicalTrials.gov ID
- NCT07814014
- Acronym / sponsor ID
- HCC / MS.24.11.2985
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- HCC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 10 Sep 2026 (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.
Real-world data from a single-center experience evaluating patients with hepatocellular carcinoma (HCC) receiving systemic therapies
Detailed description
This retrospective cohort study will be conducted at the Tropical Medicine Department of Mansoura University Hospitals, recruiting patients with advanced hepatocellular carcinoma (HCC) who will receive systemic therapy between June 2022 and November 2024. Eligible participants will include those with Child-Pugh class A liver function, ECOG performance status 0-1, and Barcelona Clinic Liver Cancer (BCLC) stage C, or stage B with diffuse, infiltrative, or extensive bilobar involvement, or progression after transarterial chemoembolization (TACE). Additional laboratory and clinical criteria will be required, such as adequate blood counts, liver and renal function, and absence of large or risky esophageal varices. Patients with Child-Pugh class B or C, early or terminal stage disease, or contraindications to systemic therapy such as active infections, autoimmune conditions, or severe comorbidities will be excluded.
Operationally, all patients will undergo comprehensive history taking, physical examination, radiological imaging (ultrasound, triphasic CT, or MRI), and laboratory testing, including liver function, renal function, virology markers, and tumor biomarkers such as alpha-fetoprotein (AFP). Follow-up assessments will be performed every three months using physical exams, imaging, and laboratory tests to monitor disease progression and treatment outcomes. Data will be systematically collected and analyzed using SPSS version 25, with qualitative variables expressed as frequencies and percentages, and quantitative data assessed for normality and described accordingly. Statistical tests such as Chi-square and correlation analyses will be applied to evaluate associations, with the ultimate aim of estimating progression-free survival and overall survival in this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients on systemic therapies | – | –1. HCC patients receiving TKI (Sorafenib and Regrofenib 2. HCC patients receiving Atezolizumab with Bevacizumab 3. HCC patients receiving Tremelimumab with Durvalumab 4 -HCC patients With positive PCR HCV treating by DAAs with systemic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HCC that are recruited to the tropical medicine inpatient department and outpatient clinics and are submitted to the inclusion and exclusion criteria from June 2022 to November 2024.
Key inclusion criteria (4 listed)
- patient with HCC
- Child-Pugh class A, B7
- Performance state 0-1 (Eastern Cooperative Oncology Group (ECOG scale).
- Barcelona Clinic Liver Cancer (BCLC) stage C or BCLC stage B with diffuse, infiltrative or extensive bilobar involvement or BCLC stage B with tumor progression after TACE.
Key exclusion criteria (3 listed)
- patient with other tumor than HCC
- Child-Turcotte-Pugh score B (8,9) and C.
- Patients eligible for treatment other than systemic therapy according to Barcelona Clinic liver cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival (OS)
Time frame: 1 year
time from initiation of systemic therapy to death from any cause
treatment response
Time frame: 1 year
m-RESIST analysis of the patients as its categories * CR - Complete response Disappearance of all arterial enhancement in all target lesions * PR - Partial response ≥30% decrease in the sum of diameters of viable tumor * SD - Stable disease Neither sufficient decrease for PR nor sufficient increase for PD * PD - Progressive disease ≥20% increase in the sum of viable tumor diameters, with an absolute increase of ≥5 mm, or appearance of new lesions/other progression criteria
progression free survival (PFS)
Time frame: one year
time from initiation of systemic therapy to radiological diseasas progression or death from any cause , whichever occur first
1 secondary outcome
efficacy of DAAs in treatment of HCV in patients with active HCV infection and HCC during receiving systemic therapy
Time frame: 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 10 Sep 2026.
- Individual participant dataSharing planned: Undecided. Will be shared after reasonable request
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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.
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 HCC - Hepatocellular Carcinoma, run by Mansoura 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 3 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 10 Sep 2026. 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 Mahmoud M El-Bendary, PhD (+201002592205, mmelbendary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 10 Sep 2026.