ClinicalTrials.gg
RecruitingNCT07814014HCCUpdated Sep 10, 2026

Real-world Insight Into Systemic Therapies for HCC: Single-center Study

An observational study in HCC - Hepatocellular Carcinoma, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Mansoura University · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 53 studies in Carcinoma, Hepatocellular with a site in Egypt — 17 open to participants now, 22 under way, 2 of them phase 3. Carcinoma, Hepatocellular · Egypt.

Planned enrollment
6th of 35
1,000 · median 110
Started
2026
with 6 others
Observational
35 of 53
12 open now
Primary completion
2027-12
later than 19 of 21 live
Registered
52nd of 53
by date
Lead sponsor
3 of 53
Mansoura University

Among the 53 studies in Carcinoma, Hepatocellular with a site in Egypt, this one is the 6th largest by planned enrollment of the 35 observational ones that give a count, is one of 7 that started in 2026, is one of 35 observational ones, reaches primary completion later than 19 of the 21 other live ones, and was the 52nd registered.

Carcinoma, Hepatocellular

3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

17 of the 53 studies in Carcinoma, Hepatocellular with a site in Egypt are open now. Recruiting first, the newest first:

11 more — sign in →

All 17 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 53 studies in Carcinoma, Hepatocellular with a site in Egypt, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • HCC - Hepatocellular Carcinoma

Keywords

  • HCC
04

Who can participate

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

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.

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

  • patient with HCC
  • class A, B7
  • Performance state 0-1 ( (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.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

This study also gives Durvalumab, Tremelimumab, Atezolizumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. overall survival (OS)

    time from initiation of systemic therapy to death from any cause

    Time frame: 1 year

  2. 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

    Time frame: 1 year

  3. progression free survival (PFS)

    time from initiation of systemic therapy to radiological diseasas progression or death from any cause , whichever occur first

    Time frame: 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

    Time frame: 1 year

Other outcomes

  1. Side effects

    adverse events related to systemic therapy of HCC

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Mansoura University Hospitals
    Al Mansurah, Dakahlia Governorate 35516, Egypt
    Recruiting
    • Mahmoud M El-Bendary · Contactmmelbendary@gmail.com · +201002592205
    • Mahmoud M El-Bendary, MD · Principal investigator
    • Nada Hussien, Msc · Sub investigator
    • Mohamed Awad · Sub investigator
    • Ahmed El-Eraky · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided — Will be shared after reasonable request

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Dec 2027, 16 months after the start.

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

Registered
Aug 27, 2026
First posted
Sep 10, 2026
StartActual
Aug 1, 2026
Primary completionEst.
Dec 15, 2027
CompletionEst.
Dec 15, 2027
Last update
Sep 10, 2026
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 Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07814014
Responsible party
Mahmoud Elbendary (Professor of Tropical Hepatogastroenterology- Tropical Medicine department, Mansoura University) — Principal investigator
First posted
Sep 10, 2026
Start date
Aug 1, 2026
Primary completion
Dec 15, 2027 (estimated)
Completion
Dec 15, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Mahmoud M El-Bendary, PhD
Contact
mmelbendary@gmail.com
+201002592205

Oversight

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

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