Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

Clinical Pharmacogenetic Study of the Efficacy and Safety of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06527495

Enrollment

150

Registered

2024-07-30

Start date

2023-01-01

Completion date

2024-12-01

Last updated

2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC, Hepatocellular Carcinoma

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.

Interventions

DRUGSorafenib

Sorafenib Tablets (200 -400 mg) twice daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Kidney function tests	At Baseline 3 month, and 6 months after treatment.	Determination of Serum creatinine concentration
Tumor markers	At Baseline, 3 month, and 6 month after treatment.	Determination of serum Alpha-Fetoprotein, AFP-L3
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)
Liver function tests.	At Baseline 3 month, and 6 months after treatment.	Determine serum level of ALT and AST
Complete blood culture	At Baseline 3 month, and 6 months after treatment.	Determination of hemoglobin concentration

Countries

Egypt

Contacts

Primary ContactMahmoud Nazih

Mahmoud.Nazih5698@pharm.aun.edu.eg00201093859868

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026