Effects of Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma: a Prospective,Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The prognosis of small liver cancer (≤5 cm) with stereotactic body radiotherapy (SBRT) is encouraging, the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, and 3-year overall survival rate around 70%. So far, there is no randomized controlled study comparing SBRT and surgical treatment for early-stage liver cancer. It is hoped that this study will further compare the efficacy of SBRT and surgery for early stage liver cancer.
详细描述
Early stage liver cancer, according to Milan criteria, are chose for this study. The patients are divided into two groups randomly. Patients in group A receive laparoscopic hepatectomy, group B patients receive SBRT.The 3-year progression free survival, 3-year local recurrence free survival, 3- year overall survival and other endpoints events were recorded and analyzed, to assess whether SBRT is non-inferior to surgery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old and above.
- •Clinical or pathological diagnosis of hepatocellular carcinoma, initial treatment (without surgery, radiotherapy, chemotherapy or targeted therapy).
- •Early-stage hepatocellular carcinoma meeting the Milan criteria: single lesion ≤ 5cm, or tumor number ≤ 3, maximum diameter ≤ 3cm, no major vascular invasion of portal vein, hepatic vein, inferior vena cava, no bile duct invasion, no lymph node and extrahepatic metastasis.
- •No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency.
- •The neutrophil count is at least 1.0*10^9/ml, and the platelet count is at least 50*10^9/ml. Hemoglobin is at least 80g/L.
- •Men or women with fertility are willing to take contraceptive measures during the trial.
- •Eastern Cooperative Oncology Group score 0-1 points.
- •Expected survival period > 3 months.
- •Voluntary participation and signing of informed consent.
排除标准
- •Patients who have undergone chemoradiation or targeted therapy for liver cancer.
- •Recent hematemesis due to portal hypertension.
- •Child-Pugh score ≥10 points.
- •Total bilirubin>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
- •who was considered unsuitable for surgery after hepatobiliary and pancreas multidisciplinary treatment（MDT） meeting.
- •Patients undergoing major surgery within 1 month of study initiation
- •Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years)
- •Researchers consider it inappropriate to participate in the test
研究组 & 干预措施
group A
laparoscopic hepatectomy (surgery)
干预措施: laparoscopic hepatectomy (surgery) (Procedure)
group B
stereotactic body radiotherapy (SBRT)
干预措施: stereotactic body radiotherapy (Radiation)
结局指标
主要结局
Progression free survival
时间窗: From the date of surgery or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years
The duration (months) between the date of surgery or the first fraction of SBRT until the date of first progression
次要结局
- Overall survival(From the date of surgery or the first fraction of SBRT until the date of death, assessed up to 3 years)
- Local recurrence free survival(From the date of surgery or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years)