Prediction of Lymph Node Metastasis in Hepatocellular Carcinoma and the Study of Individualized Radiotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 2-year overall survival
研究概览
简要总结
Objectives:
- To further validate the predictive efficacy of our established microRNA prediction model of HCC lymph node metastasis.
- To establish a precise therapeutic mode of prophylactic radiation therapy in high-risk patients with HCC with lymph node metastasis under the guidance of a microRNA prediction model.
详细描述
First, screening out patients who underwent hepatic tumor resection and pathologically diagnosed as HCC .
Then，performing the detection of miR-145, miR-31 and miR-92a by using the HCC lymph node metastasis microRNA correlation prediction model established in our previous study. The patients are judged as high risk of lymph node metastasis and low risk Patients, then high-risk patients under the condition of informed consent into the group, randomized into treatment group and control groups.
Last, Patients enrolled in the treatment group were treated with radiotherapy and followed up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients underwent liver tumor resection and pathological diagnosis of HCC in our hospital.
- •The tumor samples of these HCC patients were detected by in situ hybridization with miR-145, miR-31 and miR-92a. We used the previously established HCC lymph node metastasis microRNA prediction model to determine the patients with high-risk lymph node metastasis and low-risk patients at high risk Patients were randomly assigned into treatment group and control group with informed consent.
- •HCC patients were not receive other anti-cancer treatment.
- •Blood routine examination was normal.
- •Child-Pugh grade A, normal liver and kidney function in the normal range (including ALT or ASL within 2.5 times the normal), WBC> 3 × 109 / L, Hb> 90g / L, PLT> 50 × 109 /
- •HCC patients were not receive the history of upper abdominal radiotherapy.
- •sign the informed consent.
- •age 18-75 years old.
- •KPS score 80-100 points.
排除标准
- •accepted other anti-cancer treatment.
- •Patients was determined to be low-risk lymph node metastasis by the pre-established HCC lymph node metastasis microRNA prediction model.
- •blood and liver and kidney dysfunction.
- •can not control the infection.
- •at the same time the merger of other malignant tumors.
- •while using other experimental drugs or to participate in other clinical trials.
- •serious heart, lung, kidney disease.
- •pregnant or lactating women.
- •serious nervous system disease, can not clearly tell the treatment
研究组 & 干预措施
Radiotherapy
Patients in the experimental group, who were at high risk for lymph node metastasis, underwent radiotherapy in the lymphatic drainage area. Radiotherapy was started in lymphatic drainage areas about 1 month after HCC surgery. The range of radiotherapy was hepatic portal area, pancreas circumference, celiac trunk and abdomen Around the aortic lymph drainage area, the dose of radiation 45Gy, conventional segmentation.
干预措施: Radiotherapy (Radiation)
Blank control
Patients in the control group , who were at high risk for lymph node metastasis，were followed up.
结局指标
主要结局
2-year overall survival
时间窗: The outcome measures are assessed up to 2 years.
The therapeutic effects are mainly evaluated by the 2-year overall survival.
次要结局
未报告次要终点