Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

NCT06527495 | Recruiting Phase 1 DMC

• 1 other identifier: 00470/2023
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

HCC; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Vascular Endothelial Growth Factor A (VEGFA) genotyping

  Genetic polymorphism of VEGFA

  At Baseline, 3 month, and 6 month after treatment.

• Kinase insert domain receptor (KDR) genotyping

  Genetic polymorphism of KDR

  At Baseline, 3 month, and 6 months after treatment.

Secondary Outcomes (5)

• Tumor markers

  At Baseline, 3 month, and 6 month after treatment.

• Complete blood culture

  At Baseline 3 month, and 6 months after treatment.

• Kidney function tests

  At Baseline 3 month, and 6 months after treatment.

• Liver function tests.

  At Baseline 3 month, and 6 months after treatment.

• Safety outcome

  At Baseline, 3 month, and 6 months after treatment.

Study Arms (1)

Sorafenib

EXPERIMENTAL

Sorafenib 200 - 400 mg twice daily

Drug: Sorafenib

Interventions

Sorafenib DRUG

Sorafenib Tablets (200 -400 mg) twice daily

Sorafenib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

NLI

Shibīn al Kawm, Menoufia, 32511, Egypt

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Mahmoud Nazih

CONTACT

00201093859868; Mahmoud.Nazih5698@pharm.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 30, 2024
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)