Real-world Insight Into Systemic Therapies for HCC: Single-center Study (HCC)
Real-world Insight Into Systemic Therapies for Hepatocellular Carcinoma: a Comprehensive Single-center Study
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Mahmoud M El-Bendary, PhD
- Telefonnummer: +201002592205
- E-post: mmelbendary@gmail.com
Studieorter
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypten, 35516
- Rekrytering
- Mansoura University Hospitals
-
Kontakt:
- Mahmoud M El-Bendary
- Telefonnummer: +201002592205
- E-post: mmelbendary@gmail.com
-
Huvudutredare:
- Mahmoud M El-Bendary, MD
-
Underutredare:
- Nada Hussien, Msc
-
Underutredare:
- Mohamed Awad
-
Underutredare:
- Ahmed El-Eraky
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
HCC patients on systemic therapies
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
overall survival (OS)
Tidsram: 1 year
|
time from initiation of systemic therapy to death from any cause
|
1 year
|
|
treatment response
Tidsram: 1 year
|
m-RESIST analysis of the patients as its categories
|
1 year
|
|
progression free survival (PFS)
Tidsram: one year
|
time from initiation of systemic therapy to radiological diseasas progression or death from any cause , whichever occur first
|
one year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
efficacy of DAAs in treatment of HCV in patients with active HCV infection and HCC during receiving systemic therapy
Tidsram: 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 ,
|
1 year
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Side effects
Tidsram: 1 year
|
adverse events related to systemic therapy of HCC
|
1 year
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MS.24.11.2985
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