Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.

Sponsor

Damanhour University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06030895

Collaborator

Mransoura University (Other)

100

Enrollment

Location

Arm

12.6

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Sorafenib Tablets	Phase 4

Detailed Description

A prospective pharmcogentic study for Egyptian HCC patients treating with oral sorafenib.

Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
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.
At baseline and follow up visits after Sorafenib, all patients will be assessed for complete blood count (CBC), kidney function, liver function, liver enzymes, alpha fetoprotein (AFP) and viral markers. Moreover, triphasic pelviabdominal CT will be performed .
Blood samples will be collected for ATG10 AND IL6 genotyping.
Genetic polymorphisms of ATG10 AND IL6 will be detected by real time polymerase chain reaction (RT-PCR).

Five mls of whole blood will be collected
Extraction of genomic DNA from blood samples by DNA extraction kit.
DNA qualification will be performed by Nano drop.
Genotyping will be done by allelic discrimination using Taqman assays specific for each polymorphism.
Assays will be done according to manufacturer protocol using real time PCR machine.

Appropriate statistical tests will be conducted to evaluate the significance of the results.
Results, conclusion, discussion and recommendations will be given. Ethical Issue

Informed consent will be signed by all eligible patients before enrolling in the study.
All patients' data will be confidential.

Efficacy and Safety outcomes:

Target lesions response will be measured according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) Complete response, Partial response, Progressive disease and Stable disease.
The appropriate dose of sorafenib will be determined individually based on the patient tolerability.
Follow up will be performed for detection of tumor size using triphasic CT scan as a measure of efficacy. Moreover, all patients will be reevaluated for CBC,AFP, liver and kidney functions, in the follow up visit, to detect incidence of any adverse effects.
Patients will be asked for any side effects such as (diarrhea, anorexia, nausea, vomiting).
Patients will be followed for progression-free survival after receiving soarfenib.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

100 hepatocellular carcinoma patients100 hepatocellular carcinoma patients

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pharmacogenetic Study of Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.

Actual Study Start Date :

Dec 12, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sorafenib group 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 Sorafenib Tablets (200 -400 mg) twice daily Other Names: Nexavar

Arm

Intervention/Treatment

Experimental: Sorafenib group

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

Sorafenib Tablets (200 -400 mg) twice daily

Other Names:

Nexavar

Outcome Measures

Primary Outcome Measures

ATG10 genotyping [6 months]
Gene polymorphism
IL6 genotyping [6 months]
Gene polymorphism
Safety Outcomes [6 months]
Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.