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NCT Number: NCT06527495

Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

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.

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Key information

Conditions

HCC Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

NLI

Shibīn al Kawm, Menoufia, 32511, Egypt

Location status: Recruiting

Location contact

Imam Waked

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sorafenib

Drug

Sorafenib Tablets (200 -400 mg) twice daily

Primary outcomes

  1. Vascular Endothelial Growth Factor A (VEGFA) genotyping

    Time frame: At Baseline, 3 month, and 6 month after treatment.

    Genetic polymorphism of VEGFA

  2. Kinase insert domain receptor (KDR) genotyping

    Time frame: At Baseline, 3 month, and 6 months after treatment.

    Genetic polymorphism of KDR

Secondary outcomes

  1. Tumor markers

    Time frame: At Baseline, 3 month, and 6 month after treatment.

    Determination of serum Alpha-Fetoprotein, AFP-L3

  2. Complete blood culture

    Time frame: At Baseline 3 month, and 6 months after treatment.

    Determination of hemoglobin concentration

  3. Kidney function tests

    Time frame: At Baseline 3 month, and 6 months after treatment.

    Determination of Serum creatinine concentration

  4. Liver function tests.

    Time frame: At Baseline 3 month, and 6 months after treatment.

    Determine serum level of ALT and AST

  5. Safety outcome

    Time frame: At Baseline, 3 month, and 6 months after treatment.

    Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting, hand and foot syndrome)

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Nazih

CONTACT

[email protected]

00201093859868

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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