NCT02167711已完成2 期
Selective Internal Radiation Therapy With Yttrium-90 Resin Microspheres Followed by Gemcitabine Plus Cisplatin for Intra-hepatic Cholangiocarcinoma: A Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The current standard treatment of inoperable intrahepatic cholangiocarcinoma (bile duct cancer in the liver) is chemotherapy, which is of limited efficacy. The use of selective internal radiotherapy treatment (SIRT-Y90) is proven efficacious in patients with intra-heptic tumor. Previous experience with SIRT is safe in patients with intrahepatic cholangiocarcinoma. This study aims to study the benefits of sequential administration of SIRT followed by standard chemotherapy for treatment of inoperable intrahepatic cholangiocarcinoma.
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
- •Age>18 years
- •Histological or cytological diagnosis of cholangiocarcinoma
- •Disease not amenable to surgery
- •Predominant disease load in the liver (in case of extra-hepatic involvement, only patients with lymph nodes metastases are allowed)
- •Naïve to locoregional or systemic treatment (but patients who develop recurrent disease after surgery are suitable)
- •ECOG PS 0-1
- •At least one measurable disease lesion according to RECIST v 1.1
- •Life expectancy of 12 weeks or longer
- •Adequate hematological, renal and hepatic function
- •Platelet ≥100 x 109
- •ANC ≥ 1.5 x 109
- •Bilirubin ≤ 30µmol/L
- •Albumin ≥ 30g/L
- •ALT ≤ 3 ULN
- •INR ≤ 1.5
- •Serum creatinine ≤ 1.5 x ULN
排除标准
- •Prior malignancy except cervical carcinoma-in-situ or treated basal cell carcinoma. Any cancers treated curatively > 5 years prior to study entry are permitted.
- •Patients with extra-hepatic disease other than regional lymph node metastases.
- •Evidence of ascites or cirrhosis, as determined by clinical or radiologic assessment
- •Biliary obstruction with no possibility of drainage
- •Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
- •Prior treatment of chemotherapy for the cholangiocarcinoma
- •Prior radiation therapy to the upper abdomen
- •Complete thrombosis of the main portal vein
- •Tumor volume > 50% of the normal liver volume
- •Allergy to non-ionic contrast agents
研究组 & 干预措施
SIRT
Experimental
干预措施: SIRT Yttrium-90 (Drug)
结局指标
主要结局
Overall survival
时间窗: 2 years
次要结局
- disease control rate(2 years)
- Progression-free survival(2 years)
- Radiological response(2 years)
- Duration between timing of chemotherapy and SIRT-Y90(2 years)
- Rate and severity of toxicities(2 years)
- Serological response in CA 19.9(2 years)
研究者
CCTU
Comprehensive Clinical Trial Unit
Chinese University of Hong Kong
研究点 (1)
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