Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1-year local control rate
研究概览
简要总结
The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.
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
- •HCC (diagnosis: histological or radiological)
- •Age: 18-80
- •Number of lesions 1-3 lesions
- •Size of the lesion (or sum of 2-3 lesions) ≥ 4 cm
- •Sufficient non-tumorous liver volume (≥ 800 cm3)
- •Child Pugh Score: A5-6 or B7-8
- •BCLC A or B
- •Patient is illegible or refused surgical resection or orthotopic liver transplant
- •Blood work (within 2 weeks before registration):
- •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³)
- •Platelets ≥50,000 cells/mm³
- •AST (and ALT) < 5 times ULN
- •Serum creatinine ≤ ULN or creatinine clearance ≥ 50 mL/min
排除标准
- •Evidence of extrahepatic disease (lymph node or distant metastases)
- •Evidence of macroscopic vascular invasion
- •Evidence of an arterio-portal or arterio-venous fistulas
- •History of previous malignancy
- •Previous SIRT
- •Previous Sorafenib in the last 8 weeks
- •Pregnant and lactating females
研究组 & 干预措施
TACE+SBRT.
If a patient is eligible to participate in the project according to the in- and exclusion criteria, the patient will assigned to 1-2 sessions of TACE followed by SBRT within one month from last TACE session .
干预措施: SBRT (Radiation)
TACE+SBRT.
If a patient is eligible to participate in the project according to the in- and exclusion criteria, the patient will assigned to 1-2 sessions of TACE followed by SBRT within one month from last TACE session .
干预措施: TACE (Procedure)
结局指标
主要结局
1-year local control rate
时间窗: 12 Months
After one year from the treatment, the precentage with alive subjects with no signs of local progression (the irradiated lesion). Local progression defined as more than 20% increase in diameter of enhancing tumor on contrast-enhanced CT scan in arterial phase or a new tumor mass within the original tumor volume according to modified RECIST criteria (mRECIST)
次要结局
- Qualtiy of life based on EORTC QLQC30(12 Months)
- Quality of life based on EORTC QLQ-HCC18(12 Months)
- 1- year progression free survival(12 Months)