Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Tumor Response rate
研究概览
简要总结
The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.
详细描述
Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.
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
- None
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
- •Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma)
- •Patients aged between 18 and 80 years
- •an estimated life expectancy of more than 3 months
- •Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria
- •TNM stage III-IV
- •no evidence of cancer of another organ.
- •no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed
- •Karnofsky index of ≥60%
- •ECOG index ≥2
- •previous technically successful stenting or ENBD derange
- •Accept of informed consent
排除标准
- •Clinically significant cardiovascular disease
- •coagulation disorders
- •contraindication of Endoscopic
- •pregnant or breastfeeding women
- •known sensitivity sensitivity to investigated agents or components
- •recent invasive procedure
- •prior chemotherapy or radiotherapy for biliary cancer
- •refusal of informed consent
结局指标
主要结局
Tumor Response rate
时间窗: 3 months
The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).
次要结局
- Progression-free survival(6 months)
- overall survival(follow-up in interval of stent insertion and death (1 years))
- Adverse events(1 year)
研究者
yan liu
PhD, MD. Chairman of Department of Gastroenterology and Hepatology, 307 Hospital of PLA
307 Hospital of PLA