Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Success rate of conversion to resection
研究概览
简要总结
This study is conducted to evaluate the efficacy and safety of Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC).
详细描述
This is a bi-center, prospective study to evaluate the efficacy and safety of SIRT in patient with potentially resectable HCC.
35 patients with potentially resectable (initially unresectable) HCC will be enrolled in this study. The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added. If the patients are evaluated as resectable during follw-up, liver resection will be recommended.
The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to progression (TTP), duration of response (DOR), overall survival (OS) and adverse events (AEs).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC with diagnosis confirmed pathologically or clinically
- •No pervious treatment for HCC
- •At least one measurable intrahepatic target lesion
- •Potentially resectable HCC: tumor(s) confined to the left/right hemiliver, with/without invasion to the unilateral branch of the portal vein and/or hepatic vein
- •Disease amenable to SIRT (after evaluation)
- •Child-Pugh Class A or without cirrhosis
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA<10^3 IU/mL
- •Patients with hepatitis C need to finish the anti-HCV treatment
- •Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10^9/L, white blood cell count >3.0×10^9/L, absolute value of neutrophils >1.5×10^9/L, hemoglobin ≥85 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range
- •Life expectancy of at least 6 months
排除标准
- •Tumor involving main portal vein, bilateral branches of portal vein, or vena cava
- •tumor extention beyond one lobe of the liver
- •Bilobar tumor distribution
- •Extrahepatic metastasis
- •Decompensated liver function, including ascites, bleeding from esophageal and gastric varices, and/or hepatic encephalopathy
- •Organ (heart, kidney) dysfunction
- •HBsAg and anti-HCV antibody positive concurrently
- •History of malignancy other than HCC
- •Uncontrolled infection
- •History of HIV
- •History of organ and cell transplantation
- •Patients with bleeding tendency
结局指标
主要结局
Success rate of conversion to resection
时间窗: 3 years
The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT
次要结局
- Time to progression (TTP)(3 years)
- Objective response rate (ORR)(3 years)
- Disease control rate (DCR)(3 years)
- Progression-free survival (PFS)(3 years)
- Duration of response (DOR)(3 years)
- Overall survival (OS)(3 years)
- Adverse Events (AEs)(3 years)