Predictors of Sorafenib Response in HCC

Not yet recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: The neutrophil-to- lymphocyte ratio; Diagnostic Test: Prognostic nutrition index

• Registration Number: NCT05967429
• Lead Sponsor: Sohag University

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

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 Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-07-28
• Last Update Submitted: 2023-07-28
• Study Start: 2023-08
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-04
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• HCC recieved sorafenib

Exclusion Criteria

• Patient refuse to participate
• Patients recieving other treatment modalities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatocellular carcinoma receiving sorafenib	The neutrophil-to- lymphocyte ratio	Patient with advanced stage HCC receiving sorafenib
Hepatocellular carcinoma receiving sorafenib	Prognostic nutrition index	Patient with advanced stage HCC receiving sorafenib

Primary Outcome Measures

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