HCCPhase 1/2NCT06527495
Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma
A Phase 1/2 study testing Sorafenib in people with HCC and Hepatocellular Carcinoma, run by Assiut University at 1 site in Egypt.
Trial summary
The current study will aim to maximize the therapeutic effect and to minimize the adverse effects of sorafenib in HCC through pharmacogenomic analysis of VEGFA and KDR genetic polymorphisms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HCC, Hepatocellular Carcinoma
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Dec 2024
- Phase
- Phase 1/2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of all studied subjects ≥ 18 years old
- All patients with hepatocellular carcinoma will be included in group I.
- Patients not treated with systemic TKIs
Who cannot join
- Patients presented with liver tumors other than HCC.
- Patients with Child-Pugh grade C for liver function.
- Patients with other malignancies.
- Patients with chronic inflammatory disorders.
- Patients with severe organ dysfunction such as heart, lung, and kidney.
- Patients who cannot tolerate or are allergic to sorafenib.
- Patients with severe coagulation dysfunction were uncorrectable.
- Age less than 18 years old.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
NLI
Shibīn al Kawm, Menoufia, 32511
Imam Waked, iwaked@liver-eg.org
About this study
Official title: Clinical Pharmacogenetic Study of the Efficacy and Safety of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma
The current study will aim to maximize the therapeutic effect and to minimize the adverse effects of sorafenib in HCC through pharmacogenomic analysis of VEGFA and KDR genetic polymorphisms.
- Conditions
- HCC, Hepatocellular Carcinoma
- Being tested
- Sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Sorafenib Tablets (200 -400 mg) twice daily
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib | Experimental | Sorafenib 200 - 400 mg twice daily Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Endothelial Growth Factor A (VEGFA) genotyping
Genetic polymorphism of VEGFA
Measured: At Baseline, 3 month, and 6 month after treatment.
Kinase insert domain receptor (KDR) genotyping
Genetic polymorphism of KDR
Measured: At Baseline, 3 month, and 6 months after treatment.
Secondary outcomes (5)
Tumor markers
Determination of serum Alpha-Fetoprotein, AFP-L3
Measured: At Baseline, 3 month, and 6 month after treatment.
Complete blood culture
Determination of hemoglobin concentration
Measured: At Baseline 3 month, and 6 months after treatment.
Kidney function tests
Determination of Serum creatinine concentration
Measured: At Baseline 3 month, and 6 months after treatment.
Liver function tests.
Determine serum level of ALT and AST
Measured: At Baseline 3 month, and 6 months after treatment.
Safety outcome
Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting, hand and foot syndrome)
Measured: At Baseline, 3 month, and 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Jan 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Nazih, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527495
- Sponsor's protocol ID
- 00470/2023
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacogenetic Study of the Efficacy and Safety of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06527495
- Acronym / sponsor ID
- 00470/2023
- Conditions
- HCC, Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Jul 2024 (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.
The current study will aim to maximize the therapeutic effect and to minimize the adverse effects of sorafenib in HCC through pharmacogenomic analysis of VEGFA and KDR genetic polymorphisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Experimental | Drug: SorafenibSorafenib 200 - 400 mg twice daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of all studied subjects ≥ 18 years old
- All patients with hepatocellular carcinoma will be included in group I.
- Patients not treated with systemic TKIs
Key exclusion criteria (8 listed)
- Patients presented with liver tumors other than HCC.
- Patients with Child-Pugh grade C for liver function.
- Patients with other malignancies.
- Patients with chronic inflammatory disorders.
- Patients with severe organ dysfunction such as heart, lung, and kidney.
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 |
|---|---|---|
| SorafenibSorafenib Tablets (200 -400 mg) twice daily | Drug | Sorafenib |
Primary outcome
Vascular Endothelial Growth Factor A (VEGFA) genotyping
Time frame: At Baseline, 3 month, and 6 month after treatment.
Genetic polymorphism of VEGFA
Kinase insert domain receptor (KDR) genotyping
Time frame: At Baseline, 3 month, and 6 months after treatment.
Genetic polymorphism of KDR
5 secondary outcomes
Tumor markers
Time frame: At Baseline, 3 month, and 6 month after treatment.
Complete blood culture
Time frame: At Baseline 3 month, and 6 months after treatment.
Kidney function tests
Time frame: At Baseline 3 month, and 6 months after treatment.
Liver function tests.
Time frame: At Baseline 3 month, and 6 months after treatment.
Safety outcome
Time frame: At Baseline, 3 month, and 6 months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for HCC
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sorafenib in people with HCC and Hepatocellular Carcinoma, run by Assiut 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Jul 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Nazih (00201093859868, Mahmoud.Nazih5698@pharm.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Endothelial Growth Factor A (VEGFA) genotyping (time frame: At Baseline, 3 month, and 6 month after treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.