Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The 3-year Overall Survival
研究概览
简要总结
This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.
详细描述
Surgical resection is the primary treatment for HCC. However, it is associated with a high rate of recurrence and death. Based on the results of our retrospective study and phase II study, adjuvant radiotherapy is an effective, tolerable, and promising adjuvant regimen in patients with narrow-margin(<1cm) after hepatectomy. The 3-year and 5-year OS rates of 88.2% and 72.2% were significantly higher than the expected rates based on published reports and exceeded our predetermined threshold. However, there is no standard for the prescription dose. The high risk area of recurrence is mostly close to the blood vessels in the tumor bed, and simultaneously integrated boost (SIB) technique can optimize the target dose while protecting normal tissues. So, the investigators conducted this single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant SIB radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (< 1 cm)
- •Age > 18 years
- •Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1
- •Child-Push Score: A5-A6
- •Estimated life expectancy > 3 months
- •No distant metastasis (M0)
- •Blood routine examination: Hb≥80g/L, ANC≥1.0x10^9/L, PLT≥50x10^9/L
- •Hepatic function: alanine transaminase(ALT) and aspartate transaminase(AST) ≤1.5 times ULN; or ALT ≤ULN and AST ≤6 times ULN exclude possibility of heart disease
- •Renal function: creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN
- •Voluntary to participate and sign informed consent
排除标准
- •History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
- •Had prior abdominal irradiation
- •Had prior liver transplantation
- •Had serious myocardial disease or renal failure
- •Had moderate or severe ascites with obvious symptoms
- •Duration from surgery ≥ 3 months
结局指标
主要结局
The 3-year Overall Survival
时间窗: up to 36 months
The 3-year overall survival was calculated from the date of surgical resection to the date of death from any cause.
次要结局
- Toxic Events(up to 36 months)
- Disease-free Survival (DFS)(up to 36 months)
- Pattern of Failure(up to 36 months)
- Local Control Rate(up to 36 months)
研究者
BO CHEN
Associate Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences