Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Large Hepatocellular Carcinoma (5-10 cm) With or Without Transcatheter Arterial Chemoembolization (TACE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Local control time
研究概览
简要总结
The study aims to compare efficacy and adverse reactions of large hepatocellular carcinoma participants (5-10cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
- •single lesion and longest tumor diameter were 5-10cm;
- •CP-A or B classification;
- •Eastern Cooperative Oncology Group (ECOG) score 0-1;
- •distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm
- •unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc.
- •rejecting other therapies such as resection, liver transplantation, etc.
- •platelet count≥50 × 109/L, white blood count≥1.5 × 109/L;
- •patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.
排除标准
- •tumor thrombus;
- •lymph node involvement;
- •extrahepatic metastasis.
结局指标
主要结局
Local control time
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.
Overall survival time
时间窗: From date of randomization until the date of death from any cause, assessed up to 36 months
OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.
Progression-free survival time
时间窗: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months
PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.
次要结局
- Radiation-induced liver injury rates(From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.)
- Adverse reaction(From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.)