Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.
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ClinicalTrials.gov Identifier: NCT06030895 |
Recruitment Status :
Completed
First Posted : September 11, 2023
Last Update Posted : March 12, 2024
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma | Drug: Sorafenib Tablets | Not Applicable |
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.
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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.
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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 (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 |
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.
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Drug: Sorafenib Tablets
Sorafenib Tablets (200 -400 mg) twice daily
Other Name: Nexavar |
- 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
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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 |
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).
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
Egypt | |
Mansoura University Hospital | |
Mansoura, El-Dakahelia, Egypt, 31527 |
Study Chair: | Rehab H Werida, Ass. Prof. | Damanhour University | |
Study Director: | Noha El bassiouny, Lecturer | Damanhour University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ATG10 IL6 Genotyping |
Safety Efficacy Polymorphism |
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 |