Adjuvant Stereotactic Body Radiation for Hepatocellular Carcinoma With Microvascular Invasion and Narrow Resection Margin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Participants Without Recurrence (Disease-free).
研究概览
简要总结
Positive micro vascular invasion in early stage hepatocellular carcinoma(HCC) leads to early recurrence after surgery. Adjuvant external radiotherapy will be applied in those patients to see if disease free survival and overall survival could be approved.
详细描述
Hepatocellular carcinoma(HCC) ranks the 6th most common cancer and is the 2nd leading cause of cancer-related death globally. Surgical resection remains the most efficient therapy in early stage. Though an anatomical resection of tumor lead to an up to 70% 5-year overall survival, the existence of micro vascular invasion(MVI) caused early recurrence. Stereotactic body radiation therapy (SBRT) has been proved to be efficient in treating vascular tumor thrombosis. The investigators tried to implement this technique in adjuvant setting for HCC after surgery with MVI. Participants with early stage HCC whose tumor locates closely to the main intrahepatic vascular will be regarded as potentially-not-enough-surgical-margin candidates. Surgical resection will be carried out as scheduled and an additional silver clip will be put into the margin. Postoperative pathological examination will detect micro vascular invasion or daughter nodule. MVI-positive candidates will be eligible for enrollment. Eligible participants will be randomized to two groups, SBRT group and surgery-alone(SA) group with 1-to-1 ratio. Participants in SBRT group will receive a 35Gy limited resection margin parenchyma SBRT after surgery, while participants in SA group just get surgery. Radiation related adverse events (AE) or reaction will be recorded and intervened necessarily. All participants will be followed up by investigators every three months. DFS, OS, and AEs are end points in this study.
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
- Single (Outcomes Assessor)
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
- •solitary nodule;
- •tumor adjacent to the main trunk of hepatic vein, cava vena, or to the major branch of portal vein (including the lobar branch at least);
- •macro-vascular negative;
- •no previous treatment before surgery;
- •no previous hepatic surgery;
- •Child-Pugh score A for hepatic function.
排除标准
- •spontaneous rupture;
- •pathologically proved positive resection margin;
- •severe cirrhosis with hypersplenism or esophageal and gastric varices;
- •4-weeks postoperative examination revealed α-fetal protein(AFP) still positive or new lesion in remnant liver;
- •postoperative complications required a secondary operation or more than 3 weeks'recovery from surgery.
研究组 & 干预措施
SBRT group
Participants in SBRT group will receive SBRT as adjuvant radiotherapy for hepatocellular carcinoma with microvascular invasion and narrow resection margin.
干预措施: Stereotactic radiotherapy (Radiation)
Surgery alone group
Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
结局指标
主要结局
Participants Without Recurrence (Disease-free).
时间窗: DFS rate at 5-years after randomization.
Participants will be monitored for recurrence(disease) since enrollment. DFS was defined as time interval from randomization to the first recurrence. The unit of measure was month.
次要结局
- Overall Survival (OS) Rate.(OS rate at 5-years from randomization.)
研究者
Changying Shi
Principal Investigator
Eastern Hepatobiliary Surgery Hospital