Prospective Study of Stereotactic Body Radiation Therapy as a Bridging Therapy for Hepatocellular Carcinoma Patients on Waiting List for Liver Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Risk of classical radiation induced liver disease (RILD) after SBRT
研究概览
简要总结
This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist.
详细描述
The study population includes patients 18 years of age or older with HCC, who are accepted on waiting list for deceased donor liver transplantation (DDLT).
Patient will be assessed in a multidisciplinary committee and they will receive SBRT unless otherwise contraindicated. Patients will undergo SBRT under standard protocol.
Patients with HCC beyond University of California, San Francisco criteria (UCSF) will be removed from waitlist.
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
- •Radiological diagnosis of HCC confirmed according to AASLD criteria
- •All patients who are accepted on deceased donor waiting list
- •HCC within UCSF criteria (defined as solitary tumor <=6.5cm OR up to 3 tumors <=4.5cm, total sum <=8cm)
排除标准
- •age <18 year old;
- •Child's C cirrhosis;
- •Eastern Cooperative Oncology Group (ECOG) score >2;
- •presence of extrahepatic metastasis;
- •radiological tumor invasion to portal, hepatic vein or its branches;
- •absolute contraindications to RT (e.g. previous RT to liver);
- •positive pregnancy test;
- •unwilling or unable to adhere to study requirements and procedure;
- •any other condition, in the investigator's judgment, that increases the risk of SBRT or prevents safe trial participation.
结局指标
主要结局
Risk of classical radiation induced liver disease (RILD) after SBRT
时间窗: From time of SBRT to 3 months afterwards
Defined as elevated liver transaminases \>5 times of upper normal limit or worsening of Child's score by \>2 within 3 months after SBRT
Rate of transplant complication
时间窗: From time of transplant to 1 months afterwards
Perioperative complication will be assessed according to Clavien-Dindo classification
次要结局
- Rate of dropout from transplant waitlist(From time of enrolment to up to 2 years)
研究者
Dr. Tiffany Cho-Lam Wong
Clinical Assistant Professor
The University of Hong Kong