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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Mahmoud M El-Bendary, PhD
- Telefonnummer: +201002592205
- E-post: mmelbendary@gmail.com
Studiesteder
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypt, 35516
- Rekruttering
- Mansoura University Hospitals
-
Ta kontakt med:
- Mahmoud M El-Bendary
- Telefonnummer: +201002592205
- E-post: mmelbendary@gmail.com
-
Hovedetterforsker:
- Mahmoud M El-Bendary, MD
-
Underetterforsker:
- Nada Hussien, Msc
-
Underetterforsker:
- Mohamed Awad
-
Underetterforsker:
- Ahmed El-Eraky
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
HCC patients on systemic therapies
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
overall survival (OS)
Tidsramme: 1 year
|
time from initiation of systemic therapy to death from any cause
|
1 year
|
|
treatment response
Tidsramme: 1 year
|
m-RESIST analysis of the patients as its categories
|
1 year
|
|
progression free survival (PFS)
Tidsramme: one year
|
time from initiation of systemic therapy to radiological diseasas progression or death from any cause , whichever occur first
|
one year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
efficacy of DAAs in treatment of HCV in patients with active HCV infection and HCC during receiving systemic therapy
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Side effects
Tidsramme: 1 year
|
adverse events related to systemic therapy of HCC
|
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MS.24.11.2985
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .