Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma
Effects of Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma: a Prospective,Randomized Controlled Trial
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.
研究概览
地位
未知
详细说明
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.
研究类型
介入性
注册 (预期的)
110
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Zhejiang
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Hangzhou、Zhejiang、中国、310009
- 招聘中
- The Second Affiliated Hospital of Zhejiang University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：group A
laparoscopic hepatectomy (surgery)
|
Patients receive laparoscopic hepatectomy.
|
|
实验性的：group B
stereotactic body radiotherapy (SBRT)
|
Patients receive stereotactic body radiotherapy(SBRT)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression free survival
大体时间：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
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Local recurrence free survival
大体时间：From the date of surgery or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years
|
The duration (months) between the date of surgery or the first fraction of SBRT until the date of local recurrence
|
From the date of surgery or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years
|
|
Overall survival
大体时间：From the date of surgery or the first fraction of SBRT until the date of death, assessed up to 3 years
|
The duration (months) between the date of surgery or the first fraction of SBRT until the date of death.
|
From the date of surgery or the first fraction of SBRT until the date of death, assessed up to 3 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年6月30日
初级完成 (预期的)
2021年5月31日
研究完成 (预期的)
2021年5月31日
研究注册日期
首次提交
2018年7月2日
首先提交符合 QC 标准的
2018年7月24日
首次发布 (实际的)
2018年8月1日
研究记录更新
最后更新发布 (实际的)
2018年8月1日
上次提交的符合 QC 标准的更新
2018年7月24日
最后验证
2018年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
laparoscopic hepatectomy (surgery)的临床试验
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St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
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Seoul National University HospitalJohnson & Johnson Medical Companies完全的