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Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06030895
Recruitment Status : Completed
First Posted : September 11, 2023
Last Update Posted : March 12, 2024
Sponsor:
Information provided by (Responsible Party):
Rehab Werida, Damanhour University

Study Description
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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 Not Applicable

Detailed Description:

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

  1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
  2. 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.
  3. 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 .
  4. Blood samples will be collected for ATG10 AND IL6 genotyping.

  5. 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.
  6. Appropriate statistical tests will be conducted to evaluate the significance of the results.

  7. 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:

  1. 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.
  2. The appropriate dose of sorafenib will be determined individually based on the patient tolerability.
  3. 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.
  4. Patients will be asked for any side effects such as (diarrhea, anorexia, nausea, vomiting).
  5. Patients will be followed for progression-free survival after receiving soarfenib.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 100 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 : December 12, 2022
Actual Primary Completion Date : February 21, 2024
Actual Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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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 Name: Nexavar


Outcome Measures
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Primary Outcome Measures :
  1. ATG10 genotyping [ Time Frame: 6 months ]
    Gene polymorphism

  2. IL6 genotyping [ Time Frame: 6 months ]
    Gene polymorphism

  3. Safety Outcomes [ Time Frame: 6 months ]
    Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients refused to sign the written consent.
  2. Age > 75 years.
  3. Renal failure requiring hemo- or peritoneal dialysis
  4. History of cardiac disease
  5. Active clinically serious infections
  6. Known history of human immunodeficiency virus (HIV) infection
  7. Pregnant female
  8. Child-pugh class B and C.
  9. Performance status 3 or 4.
  10. Patient who are indicated for surgical resection or liver transplant (MDT).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06030895


Locations
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Egypt
Mansoura University Hospital
Mansoura, El-Dakahelia, Egypt, 31527
Sponsors and Collaborators
Damanhour University
Investigators
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Study Chair: Rehab H Werida, Ass. Prof. Damanhour University
Study Director: Noha El bassiouny, Lecturer Damanhour University
More Information
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Responsible Party: Rehab Werida, Associate Professor, Damanhour University
ClinicalTrials.gov Identifier: NCT06030895    
Other Study ID Numbers: sorafenib In Egyptian Patients
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: March 12, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rehab Werida, Damanhour University:
ATG10
IL6
Genotyping
 Safety
Efficacy
Polymorphism
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action