Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

NCT ID: NCT06527495

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HCC Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sorafenib

Sorafenib 200 - 400 mg twice daily

Group Type EXPERIMENTAL

Sorafenib

Intervention Type DRUG

Sorafenib Tablets (200 -400 mg) twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sorafenib

Sorafenib Tablets (200 -400 mg) twice daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mahmoud Nazih

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NLI

Shibīn al Kawm, Menoufia, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mahmoud Nazih

Role: CONTACT

00201093859868

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Imam Waked

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00470/2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.