Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.

Hepatocellular Carcinoma Clinical Trial

Official title:

Pharmacogenetic Study of Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06030895
• Other study ID #: sorafenib In Egyptian Patients
• Status: Completed
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sorafenib Tablets
Sorafenib Tablets (200 -400 mg) twice daily

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	El-Dakahelia

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ATG10 genotyping	Gene polymorphism	6 months
Primary	IL6 genotyping	Gene polymorphism	6 months
Primary	Safety Outcomes	Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting	6 months