Predictors of Sorafenib Response in HCC

July 28, 2023 updated by: Mona Mohammed Abdelrhman, Sohag University

Predictors of Sorafenib Response in Patients With Advanced Hepatocellular Carcinoma

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Hepatocellular carcinoma patient receiving sorafenib

Description

Inclusion Criteria:

  • HCC recieved sorafenib

Exclusion Criteria:

  • Patient refuse to participate
  • Patients recieving other treatment modalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of nutrition status
Time Frame: Augest 2023 to March 2024
Prognostic nutrition index
Augest 2023 to March 2024
Predictors of sorafenib response
Time Frame: Augest 2023 to March 2024
The neutrophil-to- lymphocyte ratio
Augest 2023 to March 2024
Assess the quality of life
Time Frame: Augest 2023 to March 2024
using FACT Hepatobiliary Symptom Index
Augest 2023 to March 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-07-07PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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