A Pilot Trial of Transarterial Chemoembolization With or Without Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Progression Free Survival
研究概览
简要总结
This trial is designed to be the initial prospective pilot investigation of the effectiveness of combined SBRT and TACE as bridging therapy for HCC patients awaiting liver transplanation. No prospective clinical trials regarding the combination of TACE and SBRT in pre-transplant population have been performed. We propose the trial be conducted as a pilot clinical trial with the goal of enrolling 40 patients into each arm
详细描述
The purpose of this study is to determine whether the combination of stereotatic body radiotherapy (SBRT) tand transarterial chemoembolization (TACE) is an effective "bridging therapy" for patients hepatocellular carcinoma (HCC) of the liver awaiting transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient capable of giving informed consent
- •Patient diagnosed with hepatocellular carcinoma and listed or recommended to be listed for orthotopic liver transplantation at the participating institution
- •Age > 18 years old
- •Meets clinical criteria for eligibility for TACE to the target lesion per Interventional Radiology
- •Childs' Class A or B7
- •Eastern Clinical Oncology Group performance status 0 or 1
排除标准
- •Prior radiotherapy to the upper abdomen or radioembolization of the liver
- •Prior TACE to the target lesion, RFA, or liver transplant
- •Active GI bleed within 2 weeks of study enrollment
- •Active GI ulcer disease within 4 weeks of study enrollment
- •Ascites refractory to medical therapy
- •Contraindication to receiving radiotherapy or TACE
- •Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
- •Contraindication to both contrast enhanced MRI and contrast enhanced CT (i.e. unable to undergo follow-up imaging or SBRT treatment planning)
- •Women who are pregnant
- •Participation in another concurrent treatment protocol
研究组 & 干预措施
A -Tace alone
A - TACE alone (control group, current practice and treatment)
干预措施: TACE transarterial chemoembolization (Radiation)
B - Tace combined with SBRT
B- TACE combined with SBRT (experimental group).
干预措施: TACE transarterial chemoembolization (Radiation)
B - Tace combined with SBRT
B- TACE combined with SBRT (experimental group).
干预措施: stereotatic body radiotherapy (SBRT) (Radiation)
结局指标
主要结局
Progression Free Survival
时间窗: 10 days
endpoint is OLT
次要结局
未报告次要终点