Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.

NCT06030895 | Completed

• 1 other identifier: sorafenib In Egyptian Patients
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the predictive effect of ATG10 and IL6 genetic polymorphisms in safety and efficacy of sorafenib used for the treatment of Egyptian HCC patients. Moreover, this study will determine the association between genetic polymorphisms of ATG10 and IL6 with HCC severity.

Conditions

Hepatocellular Carcinoma

Keywords

ATG10; IL6; Genotyping; Safety; Efficacy; Polymorphism

Outcome Measures

Primary Outcomes (3)

• ATG10 genotyping

  Gene polymorphism

  6 months

• IL6 genotyping

  Gene polymorphism

  6 months

• Safety Outcomes

  Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting

  6 months

Study Arms (1)

Sorafenib group

EXPERIMENTAL

100 patients diagnosed with HCC for whom Sorafenib therapy is prescribed (400 mg twice daily) or (200mg twice daily), will be recruited from Mansoura University Hospital, Mansoura, Egypt.

Drug: Sorafenib Tablets

Interventions

Sorafenib Tablets DRUG

Sorafenib Tablets (200 -400 mg) twice daily

Also known as: Nexavar

Sorafenib group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosed HCC patient.
• Child-pugh class A.
• Performance status 1-2 (ECOG scale)
• Laboratory investigation : Hemoglobin ≥8.5 mg\\dl, INR ≤2.3 ,Albumin≥2.8g\\dl, ALT and AST ≤ 3 times the ULN
• Age ≥20 years.

You may not qualify if:

• Patients refused to sign the written consent.
• Age \> 75 years.
• Renal failure requiring hemo- or peritoneal dialysis
• History of cardiac disease
• Active clinically serious infections
• Known history of human immunodeficiency virus (HIV) infection
• Pregnant female
• Child-pugh class B and C.
• Performance status 3 or 4.
• Patient who are indicated for surgical resection or liver transplant (MDT).

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, El-Dakahelia, 31527, Egypt

Location

Related Publications (1)

• El-Sheshtawy AM, Werida RH, Bahgat MH, El-Etreby S, El-Bassiouny NA. Pharmacogenomic insights: IL-23R and ATG-10 polymorphisms in Sorafenib response for hepatocellular carcinoma. Clin Exp Med. 2025 Feb 8;25(1):51. doi: 10.1007/s10238-025-01576-4.

  PMID: 39921803 DERIVED

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

Study Officials

• Rehab H Werida, Ass. Prof.

  Damanhour University

  STUDY CHAIR

• Noha El bassiouny, Lecturer

  Damanhour University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 100 hepatocellular carcinoma patients

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 11, 2023
• Study Start: December 12, 2022
• Primary Completion: February 21, 2024
• Study Completion: March 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)