Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.

• ClinicalTrials.gov Identifier: NCT06030895
• Recruitment Status: Completed
• First Posted: September 11, 2023
• Last Update Posted: March 12, 2024
• Sponsor: Damanhour University
• Information provided by (Responsible Party): Rehab Werida, Damanhour University

Tracking Information

• First Submitted Date: September 3, 2023
• First Posted Date: September 11, 2023
• Last Update Posted Date: March 12, 2024
• Actual Study Start Date: December 12, 2022
• Actual Primary Completion Date: February 21, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 3, 2023)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.
• Official Title: Pharmacogenetic Study of Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.
• 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.

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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

100 hepatocellular carcinoma patients

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Hepatocellular Carcinoma

Intervention

Drug: Sorafenib Tablets

Sorafenib Tablets (200 -400 mg) twice daily

Other Name: Nexavar

Study Arms

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.

Intervention: Drug: Sorafenib Tablets

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 3, 2023): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 1, 2024
• Actual Primary Completion Date: February 21, 2024 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT06030895
• Other Study ID Numbers: sorafenib In Egyptian Patients
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Rehab Werida, Damanhour University
• Original Responsible Party: Same as current
• Current Study Sponsor: Damanhour University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Rehab H Werida, Ass. Prof.; Damanhour University
• Study Director: Noha El bassiouny, Lecturer; Damanhour University

• PRS Account: Damanhour University
• Verification Date: March 2024