NCT06527495招募中1 期
Clinical Pharmacogenetic Study of the Efficacy and Safety of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Vascular Endothelial Growth Factor A (VEGFA) genotyping
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Sorafenib
Experimental
Sorafenib 200 - 400 mg twice daily
干预措施: Sorafenib (Drug)
结局指标
主要结局
Vascular Endothelial Growth Factor A (VEGFA) genotyping
时间窗: At Baseline, 3 month, and 6 month after treatment.
Genetic polymorphism of VEGFA
Kinase insert domain receptor (KDR) genotyping
时间窗: At Baseline, 3 month, and 6 months after treatment.
Genetic polymorphism of KDR
次要结局
- Tumor markers(At Baseline, 3 month, and 6 month after treatment.)
- Liver function tests.(At Baseline 3 month, and 6 months after treatment.)
- Kidney function tests(At Baseline 3 month, and 6 months after treatment.)
- Safety outcome(At Baseline, 3 month, and 6 months after treatment.)
- Complete blood culture(At Baseline 3 month, and 6 months after treatment.)
研究者
Mahmoud Nazih
Principal Investigator
Assiut University
研究点 (1)
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