Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

July 26, 2024 updated by: Mahmoud Nazih, Assiut University

Clinical Pharmacogenetic Study of the Efficacy and Safety 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib
Sorafenib 200 - 400 mg twice daily
Drug: Sorafenib
Sorafenib Tablets (200 -400 mg) twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular Endothelial Growth Factor A (VEGFA) genotyping
Time Frame: At Baseline, 3 month, and 6 month after treatment.
Genetic polymorphism of VEGFA
At Baseline, 3 month, and 6 month after treatment.
Kinase insert domain receptor (KDR) genotyping
Time Frame: At Baseline, 3 month, and 6 months after treatment.
Genetic polymorphism of KDR
At Baseline, 3 month, and 6 months after treatment.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 13, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 26, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00470/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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