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Trial Title:
Predictors of Sorafenib Response in HCC
NCT ID:
NCT05967429
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Nutrition assessment
HCC
Sorafenib
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
The neutrophil-to- lymphocyte ratio
Description:
It was calculated by dividing the neutrophil count by the lymphocyte count.
Arm group label:
Hepatocellular carcinoma receiving sorafenib
Other name:
NLR
Intervention type:
Diagnostic Test
Intervention name:
Prognostic nutrition index
Description:
It was calculated using the following formula: serum albumin (g/L) + 0.005 × total
lymphocyte count/μL
Arm group label:
Hepatocellular carcinoma receiving sorafenib
Other name:
PNI
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.
Criteria for eligibility:
Study pop:
Hepatocellular carcinoma patient receiving sorafenib
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- HCC recieved sorafenib
Exclusion Criteria:
- Patient refuse to participate
- Patients recieving other treatment modalities
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Start date:
August 2023
Completion date:
June 2024
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05967429
