Pharmacogenetic Study in Hepatocellular Carcinoma Patients Underwent TACE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Angiopoietin (ANG-2) rs55633437.
研究概览
简要总结
evaluate the prognostic value of genetic polymorphisms in HCC Egyptian patients undergoing TACE using lipiodol and doxorubicin.
详细描述
Research Objectives This study aims to determine the predictive effect of ANG-2 and IL28B genetic polymorphisms in safety and efficacy of doxorubicin and lipiodol used for the treatment of Egyptian HCC patients. Moreover, this study will determine the association between genetic polymorphisms of ANG-2 and IL28B with HCC severity.
Patients & Methods Study design Our study is a prospective study for HCC patients undergoing TACE of doxorubicin and lipiodol.
Sample Size Based on previous published incidence of gene it will be at least 116 patients. Efficacy and Safety
- Target lesions response will be measured according to modified Response Evaluation Criteria in Solid Tumors (RECIST) to (15):
Complete response, Partial response, Progressive disease and Stable disease. 2. Repeated TACE sessions will be planned individually based on the tumor response to the treatment protocol. 3. 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, liver and kidney functions, in the follow up visit, to detect incidence of any adverse effects. 4. Patients will be asked for any side effects such as (myelosuppression, anorexia, nausea, vomiting, and/or alopecia). 5. Patients will be followed for progression-free survival after receiving TACE.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients should fulfill the following criteria:
- •A diagnosed HCC patient.
- •Age ≥20 years.
- •Patients with adequate organ function.
- •HCC not eligible for curative measures (radiofrequency, microwave and surgery).
排除标准
- •Patient will be excluded for any of the following:
- •Patients refused to sign the written consent.
- •Age > 75 years.
- •The presence of major portal vein thrombosis.
- •Extrahepatic metastases.
- •Hepatic encephalopathy.
- •Current infection.
- •Gastrointestinal bleeding within a month.
- •Uncontrolled ascites.
- •Serum bilirubin > 3.0 mg/dl, serum albumin < 2.8 g/dl, serum creatinine concentration > 1.5 mg/dl, white blood cell counts < 3,000/mm3 and platelet counts < 30,000/mm
- •Patients with other types of malignancy, advanced organ failure, and advanced medical co-morbidity.
- •Pregnant females.
研究组 & 干预措施
HCC patients
116 hepatocellular carcinoma patients underwent TACE
干预措施: Doxorubicin (Drug)
HCC patients
116 hepatocellular carcinoma patients underwent TACE
干预措施: Lipiodol (Drug)
结局指标
主要结局
Angiopoietin (ANG-2) rs55633437.
时间窗: 1 month
Gene
Interleukin 28 B (IL28B) rs12979860.
时间窗: 1 month
Gene
次要结局
未报告次要终点
研究者
Rehab Werida
Principal Investigator
Damanhour University