Hepatocellular CarcinomaNCT06030895
Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.
A study testing Sorafenib Tablets in people with Hepatocellular Carcinoma, run by Damanhour University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sorafenib Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Pregnant female
- Child-pugh class B and C.
- Performance status 3 or 4.
- Patient who are indicated for surgical resection or liver transplant (MDT).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sorafenib Tablets
- Keywords
- ATG10, IL6, Genotyping, Safety, Efficacy, Polymorphism
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib TabletsDrug
Also called Nexavar
Sorafenib Tablets (200 -400 mg) twice daily
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib group | Experimental | 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. Receives: Drug: Sorafenib Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATG10 genotyping
Gene polymorphism
Measured: 6 months
IL6 genotyping
Gene polymorphism
Measured: 6 months
Safety Outcomes
Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start12 Dec 2022
- Primary completion21 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 100 hepatocellular carcinoma patients
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass. Prof., Study chair, Damanhour UniversityNoha El bassiouny, Lecturer, Study director, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030895
- Sponsor's protocol ID
- sorafenib In Egyptian Patients
- Status last verified
- Mar 2024
- First submitted
- 3 Sep 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Sheshtawy AM, Werida RH, Bahgat MH, El-Etreby S, El-Bassiouny NA. Pharmacogenomic insights: IL-23R and ATG-10 polymorphisms in Sorafenib response for hepatocellular carcinoma. Clin Exp Med. 2025 Feb 8;25(1):51. doi: 10.1007/s10238-025-01576-4.
PubMed 39921803
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic Study of Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT06030895
- Acronym / sponsor ID
- sorafenib In Egyptian Patients
- Conditions
- Hepatocellular Carcinoma
- Keywords
- ATG10, IL6, Genotyping, Safety, Efficacy, Polymorphism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 100 hepatocellular carcinoma patients
| Arm | Type | Receives |
|---|---|---|
| Sorafenib group | Experimental | Drug: Sorafenib Tablets100 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib TabletsAlso: NexavarSorafenib Tablets (200 -400 mg) twice daily | Drug | Sorafenib group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 39921803El-Sheshtawy AM, Werida RH, Bahgat MH, El-Etreby S, El-Bassiouny NA. Pharmacogenomic insights: IL-23R and ATG-10 polymorphisms in Sorafenib response for hepatocellular carcinoma. Clin Exp Med. 2025 Feb 8;25(1):51. doi: 10.1007/s10238-025-01576-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rehab H Werida, Ass. Prof. study chair
Damanhour University
Noha El bassiouny, Lecturer study director
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sorafenib Tablets in people with Hepatocellular Carcinoma, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ATG10 genotyping (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06030895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.