Efficacy and Safety of Drug Eluting Beads TACE in Treatment of HCC in Egyptian Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Number of Participants With Complete Response
研究概览
简要总结
This study aimed to to compare the conventional transarterial chemoembolization (cTACE) with chemoembolization using doxorubicin drug eluting beads (DEB-TACE) for the treatment of hepatocellular carcinoma regarding short term efficacy and safety in first 3 months after embolization
详细描述
This prospective case control was conducted at the Department of Tropical Medicine and HCC Clinic, Ain Shams University Hospitals (Cairo, Egypt), The patients were divided according to the line of treatment into 2 groups:
- Group (I): Twenty-five patients underwent Chemoembolization with Drug eluting beads.
- Group (II): Twenty-five patients underwent conventional Chemoembolization (cTACE)
The total number of procedures was 77 sessions (37 sessions of TACE with beads and 40 sessions of conventional TACE).Post-procedure follow up:
Schedule of follow up:
All included patients were checked at:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of HCC according to the European association of study of liver diseases
- •Early stage HCC (Stage A), using the Barcelona Clinic Liver Cancer (BCLC) staging system, (single or 3 nodules < 3cm PS 0) whenever curative measures were contraindicated and BCLC stage B (intermediate HCC).
- •Patent portal vein and its main branches
- •Informed consent from all participants before enrollment in the study.
排除标准
- •Patients with Child class C according to Child classification (BCLC D).
- •Patients with diffuse HCC (non-measurable lesion).
- •Patients with thrombosis of main portal vein or one of its main branches (BCLC C).
- •Patients with extra hepatic invasion.
- •patients refused to participate in the study
研究组 & 干预措施
group 1 Drug eluting beads intervention
Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)
干预措施: TACE with Drug Eluting Beads procedure (Drug)
group 2 Conventional TACE intervention
Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique
干预措施: Trans-arterial chemoembolization (TACE) (Drug)
结局指标
主要结局
Number of Participants With Complete Response
时间窗: 1 year
Assessment of Radiological response by modified RECIST radiological criteria after treatment (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.")
次要结局
未报告次要终点
研究者
Iman Fawzy Montasser
Associate professor of tropical medicine , Ain Shams university
Ain Shams University