- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06030895
Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.
March 9, 2024 updated by: Rehab Werida, Damanhour University
Pharmacogenetic Study of Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rehab H Werida, Ass. Prof.
- Phone Number: +201005359968
- Email: rehabwrieda@pharm.dmu.edu.eg
Study Contact Backup
- Name: Asmaa Elsheshtawy, Bachlor
- Email: a.elsheshtawy00043@pharm.dmu.edu.eg
Study Locations
-
-
El-Dakahelia
-
Mansoura, El-Dakahelia, Egypt, 31527
- Mansoura University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Sorafenib Tablets (200 -400 mg) twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ATG10 genotyping
Time Frame: 6 months
|
Gene polymorphism
|
6 months
|
IL6 genotyping
Time Frame: 6 months
|
Gene polymorphism
|
6 months
|
Safety Outcomes
Time Frame: 6 months
|
Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Noha El bassiouny, Lecturer, Damanhour University
- Study Chair: Rehab H Werida, Ass. Prof., Damanhour University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2022
Primary Completion (Actual)
February 21, 2024
Study Completion (Actual)
March 1, 2024
Study Registration Dates
First Submitted
September 3, 2023
First Submitted That Met QC Criteria
September 3, 2023
First Posted (Actual)
September 11, 2023
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 9, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Sorafenib
Other Study ID Numbers
- sorafenib In Egyptian Patients
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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