Endoscopic Radiofrequency Ablation Combined With Gemcitabine and S-1 in Paitiens for Unresectable Cholangiocarcinoma：A Randomized Open-label Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- survival time
研究概览
简要总结
Extrahepatic cholangiocarcinoma is a malignant tumor that is highly malignant and difficult to diagnose and treat early. Endobiliary radiofrequency ablation (RFA) has been reported to be a beneficial treatment option for palliation of malignant biliary strictures. Within the bile duct, RFA appears to be safe and may result in decreased tumor ingrowth. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to compare the efficacy and safety of RAF combined with Gemcitabine and S-1 in patients with unresectable cholangiocarcinoma.
详细描述
Over 60 % of common bile duct (CBD) obstructions are due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis. Biliary drainage with placement of metal or plastic stents for palliation is the therapy of choice in this set of patients.
Radiofrequency ablation (RFA) is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Many studies showed RFA with biliary stent was a beneficial treatment option for palliation of malignant biliary strictures. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma.
The aim of this study is to compare the efficacy and safety of RAF combined with Gemcitabine and S-1 in patients with unresectable cholangiocarcinoma
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
- Single (Outcomes Assessor)
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
- •Obtention of a written informed consent.
- •Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA.
- •Patient with Karnofsky score > 60， ECOG>level 2
- •Patient capable of fill in the quality of life questionnaire
- •For the first time treatment
- •CT, MRCP, EUS and other examinations indicate that the tumor has locally infiltrated large blood vessels and cannot be surgically removed
- •Exclusion Criteria
- •No written informed consent
- •Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
- •Pregnant, parturient or breastfeeding women
- •Serious abnormalities in liver and kidney function and coagulation function
- •The ERCP guide wire cannot pass the stricture due to severe biliary stricture
- •Merge with other malignant tumors
- •Use other treatments that may affect the observation, such as radioactive particles or seed stent implantation, P53 injection, oral chemotherapy, interventional therapy, etc.
排除标准
- 未提供
研究组 & 干预措施
RAF combined with gemcitabine and S-1 group
Patients will receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement, and be treated with gemcitabine and S-1 within 1 month after RFA.
干预措施: radiofrequency ablation (Device)
RAF combined with gemcitabine and S-1 group
Patients will receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement, and be treated with gemcitabine and S-1 within 1 month after RFA.
干预措施: Chemotherapy drug (Drug)
RFA-only gruop
Patients will only receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement
干预措施: radiofrequency ablation (Device)
结局指标
主要结局
survival time
时间窗: two years
The period from endoscopic treatment to patient death or the last day of study
次要结局
- Progression free survival(two years)
- Adverse events(one month)
- Stent patency time(two years)
研究者
Jianfeng Yang
Director
First People's Hospital of Hangzhou