Stereotactic Body Radiation Therapy With Deep Inspiration Breath Hold for Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization and Lipiodol Marking
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recognition of lipiodol marking
研究概览
简要总结
Stereotactic Body Radiation Therapy (SBRT) for hepatocellular carcinoma (HCC) with radical dose achieved similar results with radiofrequency ablation (RF) and radical surgery, according to previous studies. For tumors near great blood vessels or with a diameter more than 2cm, SBRT performs even better than RF. In current clinical practice of SBRT for small HCC, registration is achieved by planting metal markers near the tumor, which has several disadvantages: 1. the operation is invasive, increase the risk of bleeding in patients with cirrhosis; 2. the operation is of no therapeutic value; 3. metal markers can only be planted outside the tumor to avoid transplantation, which compromises the accuracy of registration via CBCT. This study aims to adopt a new method of registration, transcatheter arterial chemoembolization (TACE) and lipiodol marking, to analyze the recognition and clarity of lipiodol on CBCT images, set-up errors and treatment efficacy. Therefore to provide data to support TACE and lipiodol marking over metal marker planting.
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
- •Clinically or pathologically confirmed hepatocellular carcinoma.
- •Liver-GTV >700ml; intrahepatic metastasis allowed but only one tumor is to be treated with SBRT and others stable for more than 3 months; distant metastasis allowed but stable for more than 6 months.
- •Expected gastric/duodenum/small intestine Dmax 25-35Gy; colon Dmax 28-38Gy. Prescription dose 40Gy/5-10f.
- •DIBH training prior to SBRT to achieve 36 seconds breath hold.
- •Life expectancy > 3 months.
- •Child-Pugh A5, A6 or B
- •Liver function: ALT within 1.5 times of upper limit; ALT within 0.5 times of upper limit and AST within 6 times of upper limit, excluding cardiac infarction; ALT within 0.5-1.5 times of upper limit and AST within 1.5 times of upper limit
- •Normal ECG, without severe cardiac dysfunction
- •Kidney function: CRE, BUN within 1.5 times of upper limit.
- •CBC: Hb≥80g/L，ANC≥1.0×109 /L，PLT≥40×109 /L
- •Without hemorrhagic tendency.
- •Voluntarily participate in this trial and sign consent form.
排除标准
- •Participants of other clinical trials.
- •History of abdomen radiation therapy or liver transplantation.
- •History of severe cardiovascular, kidney or liver disease.
- •Pregnancy or lactation.
- •Suspected or confirmed of drug or alcohol abuse.
- •History of severe mental or neurological disease, compromising the ability to consent and/or AE diagnosis.
- •Allergic to lipiodol.
结局指标
主要结局
Recognition of lipiodol marking
时间窗: During the radiotherapy
Judged by 2 technicians and 1 physician on CBCT images. High recognition is concluded when all three consider it easily registered. Moderate recognition is concluded when two consider it easily registered. Poor recognition is concluded when one or none consider it easily registered.
ORR
时间窗: 6 months after radiotherapy
Objective response rate
次要结局
- LCR(12 months and 24 months after radiotherapy)
- Completion rate of treatment model(1 months after TACE)
- PFS(12 months and 24 months after radiotherapy)
- Frequency of AE(up to 24 months)
研究者
BO CHEN
Physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences