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NCT Number: NCT07814014

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

Real-world data from a single-center experience evaluating patients with hepatocellular carcinoma (HCC) receiving systemic therapies

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location status: Recruiting

Location contact

Ahmed El-Eraky

SUB_INVESTIGATOR

Mahmoud M El-Bendary

CONTACT

[email protected]

+201002592205

Mahmoud M El-Bendary, MD

PRINCIPAL_INVESTIGATOR

Mohamed Awad

SUB_INVESTIGATOR

Nada Hussien, Msc

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Primary outcomes

  1. overall survival (OS)

    Time frame: 1 year

    time from initiation of systemic therapy to death from any cause

  2. 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
  3. 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

Secondary outcomes

  1. efficacy of DAAs in treatment of HCV in patients with active HCV infection and HCC during receiving systemic therapy

    Time frame: 1 year

    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

Other outcomes

  1. Side effects

    Time frame: 1 year

    adverse events related to systemic therapy of HCC

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud M El-Bendary, PhD

CONTACT

[email protected]

+201002592205

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Real-world Insight Into Systemic Therapies for Hepatocellular Carcinoma: a Comprehensive Single-center Study

Acronym: HCC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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