Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

Assiut University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma; HCC

Treatments: Drug: Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT06527495

00470/2023

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Sorafenib

Experimental group

Description:

Sorafenib 200 - 400 mg twice daily

Treatment:

Drug: Sorafenib