Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

Phase 1

Recruiting

• Conditions: Hepatocellular Carcinoma; HCC
• Interventions: Drug: Sorafenib

• Registration Number: NCT06527495
• Lead Sponsor: Assiut University

Brief Summary

The current study will aim to maximize the therapeutic effect and to minimize the adverse effects of sorafenib in HCC through pharmacogenomic analysis of VEGFA and KDR genetic polymorphisms.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-13
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age of all studied subjects ≥ 18 years old
• All patients with hepatocellular carcinoma will be included in group I.
• Patients not treated with systemic TKIs

Exclusion Criteria

• Patients presented with liver tumors other than HCC.
• Patients with Child-Pugh grade C for liver function.
• Patients with other malignancies.
• Patients with chronic inflammatory disorders.
• Patients with severe organ dysfunction such as heart, lung, and kidney.
• Patients who cannot tolerate or are allergic to sorafenib.
• Patients with severe coagulation dysfunction were uncorrectable.
• Age less than 18 years old.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sorafenib	Sorafenib	Sorafenib 200 - 400 mg twice daily

Primary Outcome Measures

Name	Time	Method
Vascular Endothelial Growth Factor A (VEGFA) genotyping	At Baseline, 3 month, and 6 month after treatment.	Genetic polymorphism of VEGFA
Kinase insert domain receptor (KDR) genotyping	At Baseline, 3 month, and 6 months after treatment.	Genetic polymorphism of KDR

Secondary Outcome Measures

Name	Time	Method
Tumor markers	At Baseline, 3 month, and 6 month after treatment.	Determination of serum Alpha-Fetoprotein, AFP-L3
Liver function tests.	At Baseline 3 month, and 6 months after treatment.	Determine serum level of ALT and AST
Kidney function tests	At Baseline 3 month, and 6 months after treatment.	Determination of Serum creatinine concentration
Safety outcome	At Baseline, 3 month, and 6 months after treatment.	Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting, hand and foot syndrome)
Complete blood culture	At Baseline 3 month, and 6 months after treatment.	Determination of hemoglobin concentration

Trial Locations

Locations (1)

NLI; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt