NCT06527495
Recruiting
Phase 1
Clinical Pharmacogenetic Study of the Efficacy and Safety of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma
Overview
- Phase
- Phase 1
- Intervention
- Sorafenib
- Conditions
- HCC
- Sponsor
- Assiut University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Vascular Endothelial Growth Factor A (VEGFA) genotyping
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Mahmoud Nazih
Principal Investigator
Assiut University
Eligibility Criteria
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.
Arms & Interventions
Sorafenib
Sorafenib 200 - 400 mg twice daily
Intervention: Sorafenib
Outcomes
Primary Outcomes
Vascular Endothelial Growth Factor A (VEGFA) genotyping
Time Frame: At Baseline, 3 month, and 6 month after treatment.
Genetic polymorphism of VEGFA
Kinase insert domain receptor (KDR) genotyping
Time Frame: At Baseline, 3 month, and 6 months after treatment.
Genetic polymorphism of KDR
Secondary Outcomes
- Tumor markers(At Baseline, 3 month, and 6 month after treatment.)
- Liver function tests.(At Baseline 3 month, and 6 months after treatment.)
- Kidney function tests(At Baseline 3 month, and 6 months after treatment.)
- Safety outcome(At Baseline, 3 month, and 6 months after treatment.)
- Complete blood culture(At Baseline 3 month, and 6 months after treatment.)
Study Sites (1)
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