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Trial Title:
Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma
NCT ID:
NCT06527495
Condition:
HCC
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Sorafenib
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sorafenib
Description:
Sorafenib Tablets (200 -400 mg) twice daily
Arm group label:
Sorafenib
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
NLI
Address:
City:
Shibīn Al Kawm
Zip:
32511
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Imam Waked
Email:
iwaked@liver-eg.org
Start date:
January 1, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06527495
