Predictors of Sorafenib Response in HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

Predictors of Sorafenib Response in Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05967429
• Other study ID #: Soh-Med-23-07-07PD
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Sohag University
• Contact: Mona Abdelrahmam, MD
• Phone: 01021025895
• Email: monamohamed[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• HCC recieved sorafenib

Exclusion Criteria:

• Patient refuse to participate

• Patients recieving other treatment modalities

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• The neutrophil-to- lymphocyte ratio
It was calculated by dividing the neutrophil count by the lymphocyte count.
• Prognostic nutrition index
It was calculated using the following formula: serum albumin (g/L) + 0.005 × total lymphocyte count/µL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (1)

Takagi K, Buettner S, Ijzermans JNM. Prognostic significance of the controlling nutritional status (CONUT) score in patients with colorectal cancer: A systematic review and meta-analysis. Int J Surg. 2020 Jun;78:91-96. doi: 10.1016/j.ijsu.2020.04.046. Epub 2020 Apr 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of nutrition status	Prognostic nutrition index	Augest 2023 to March 2024
Primary	Predictors of sorafenib response	The neutrophil-to- lymphocyte ratio	Augest 2023 to March 2024
Primary	Assess the quality of life	using FACT Hepatobiliary Symptom Index	Augest 2023 to March 2024