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Predictors of Sorafenib Response in HCC

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05967429
Collaborator
(none)
80
Enrollment
10
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Evaluating the nutrition status of patients with advanced HCC who received sorafenib.

Using the pretreatment nutrition status and quality of life as predictors to sorafenib response

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: The neutrophil-to- lymphocyte ratio
  • Diagnostic Test: Prognostic nutrition index

Detailed Description

This a cross sectional study will be conducted on 100 HCC treated with sorafenib Data were gathered from medical records, including

age sex body weight and height (BMI) pre-therapy laboratory counts of white cells, neutrophils, lymphocytes, monocyte, hemoglobin and platelets; bilirubin, albumin and globulin concentration, AST, ALT, AFP, PT and CONC

Barcelona Clinic Liver Cancer Stage (BCLC) of all patients

The neutrophil-to- lymphocyte ratio (NLR) was calculated by dividing the neutrophil count by the lymphocyte count.

The platelet- to-lymphocyte ratio (PLR) was calculated by dividing the platelet count by the lymphocyte count.

Weight loss difference after treatment Portal hypertension was defined as presence of either collaterals on radiological examination, esophageal varices by upper gastrointestinal endoscopy and/or thrombocytopenia.

Quality of life assessment. QoL was assessed using FACT Hepatobiliary Symptom Index (FHSI-8) Questionnaire. QoL was assessed at base line and 3-6 months after start of treatment.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Predictors of Sorafenib Response in Patients With Advanced Hepatocellular Carcinoma
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Hepatocellular carcinoma receiving sorafenib

Patient with advanced stage HCC receiving sorafenib

Diagnostic Test: The neutrophil-to- lymphocyte ratio
It was calculated by dividing the neutrophil count by the lymphocyte count.
Other Names:
  • NLR

    • Diagnostic Test: Prognostic nutrition index
    It was calculated using the following formula: serum albumin (g/L) + 0.005 × total lymphocyte count/μL
    Other Names:
  • PNI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. assessment of nutrition status [Augest 2023 to March 2024]

      Prognostic nutrition index

    2. Predictors of sorafenib response [Augest 2023 to March 2024]

      The neutrophil-to- lymphocyte ratio

    3. Assess the quality of life [Augest 2023 to March 2024]

      using FACT Hepatobiliary Symptom Index

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • HCC recieved sorafenib
    Exclusion Criteria:

    • Patient refuse to participate

    • Patients recieving other treatment modalities

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sohag University

    Investigators

    • Study Director: Amr Zagloul, MD, Sohag University
    • Study Chair: Ahmed othman, MD, Sohag University
    • Study Chair: Rafat Abd El Aal, MD, Sohag University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mona Mohammed Abdelrhman, Principal investigator, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05967429
    Other Study ID Numbers:
    • Soh-Med-23-07-07PD
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mona Mohammed Abdelrhman, Principal investigator, Sohag University
    Nutrition assessment
    HCC
    Sorafenib
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Aug 1, 2023