Effects of Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma: a Prospective, Randomized Controlled Study
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) who had underwent stereotactic body radiotherapy (SBRT) is encouraging, with the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, 3-year overall survival rate around 70%. Local ablation therapy has become the standard treatment for recurrent liver cancer after surgery and interventional treatment. The ablation rate of tumors with a diameter of 3.1-5.0 cm reached 90%. The 1, 2, and 3-year survival rates had been reported to be 89%, 74%, and 60%, respectively, which is similar to that of surgical resection. At present, there is no randomized controlled study of SBRT and microwave ablation (MWA) for small liver cancer. It is hoped that this study will further compare the efficacy of SBRT and MWA for recurrent small hepatocellular carcinoma.
详细描述
Recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chose for this study. The patients are divided into two groups randomly. Patients in group A receive MWA, 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 MWA.
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 recurrent hepatocellular carcinoma after initial treatment (surgery, TACE, radiofrequency ablation, etc.)
- •Small 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
- •Obvious cirrhosis, 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.
- •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
MWA
Patients receive microwave ablation (MWA)
干预措施: microwave ablation (MWA) (Device)
SBRT
Patients receive stereotactic body radiotherapy (SBRT)
干预措施: stereotactic body radiotherapy (SBRT) (Radiation)
结局指标
主要结局
progression free survival
时间窗: From the date of MWA or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years.
Progression-free survival (PFS) was measured from the date of MWA or the first fraction of SBRT until the date of first progression (local or distant).
次要结局
- overall survival(From the date of MWA or the first fraction of SBRT until the date of death, assessed up to 3 years)
- local recurrence free survival(From the date of MWA or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years)