HCC - Hepatocellular Carcinoma
Conditions
Keywords
HCC
Brief summary
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.
Interventions
None listed
Sponsors
Mansoura University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | 1 year | time from initiation of systemic therapy to death from any cause |
| treatment response | 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) | one year | time from initiation of systemic therapy to radiological diseasas progression or death from any cause , whichever occur first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of DAAs in treatment of HCV in patients with active HCV infection and HCC during receiving systemic therapy | 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 |
Countries
Egypt
Contacts
CONTACTMahmoud M El-Bendary, PhD
Outcome results
None listed