Clinical trial · Interventional
Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.
Pharmacogenetic Study of Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.
NCT06030895CI-TRIAL-00074904completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib Tablets | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib group
- description
- 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.
- interventionNames
- Drug: Sorafenib Tablets
Primary outcomes (3)
- measure
- ATG10 genotyping
- timeFrame
- 6 months
- description
- Gene polymorphism
- measure
- IL6 genotyping
- timeFrame
- 6 months
- description
- Gene polymorphism
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. A diagnosed HCC patient. 2. Child-pugh class A. 3. Performance status 1-2 (ECOG scale) 4. Laboratory investigation : Hemoglobin ≥8.5 mg\\dl, INR ≤2.3 ,Albumin≥2.8g\\dl, ALT and AST ≤ 3 times the ULN 5. Age ≥20 years. Exclusion Criteria: 1. Patients refused to sign the written consent. 2. Age \> 75 years. 3. Renal failure requiring hemo- or peritoneal dialysis 4. History of cardiac disease 5. Active clinically serious infections 6. Known history of human immunodeficiency virus (HIV) infection 7. Pregnant female 8. Child-pugh class B and C. 9. Performance status 3 or 4. 10. Patient who are indicated for surgical resection or liver transplant (MDT).
References
Publications (1)
- DERIVEDEl-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. PMID 39921803