Radiation-Emitting Metallic Stents (REMS) Combined With Trans-Arterial Infusion (TAI) Versus Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this randomized controlled study is to evaluate the efficacy and safety of the Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) for unresectable hilar cholangiocarcinoma.
详细描述
This is a multicentric, open-labal, randomized controlled trial which aims to evaluate the efficacy and safety of Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) versus Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma. The primary hypotheses are that Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) is superior to Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) with respect to Over survival(OS). The primary endpoint is overall survival. The secondary endpoints include quality of life, progression free survival, relief of jaundice, patency, and adverse events.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically or histopathologically diagnosis of cholangiocarcinoma
- •With symptoms such as jaundice related to biliary obstruction
- •Biliary obstruction of Bismuth-Correlate Classification Type III or IV
- •Unresectable disease confirmed by multidisciplinary team
- •Maximum diameter of lesion ≤3 cm
- •Liver function of Child-Pugh A or B
- •18 years older
- •With an expected survival time ≥ 3 months
- •With an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Meet the following laboratory test parameters: hematologic function (absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L; hemoglobin ≥ 90 g/L; INR < 1.7 or prolonged prothrombin time not more than 4 seconds); liver function (ALT/AST not more than 5 times the upper limit of normal; albumin ≥ 28 g/L); renal function (serum creatinine not more than 1.5 times the upper limit of normal)
排除标准
- •Presence of distant metastases
- •With another malignancy type other than cholangiocarcinoma
- •Previous history of biliary stent placement
- •Moderate to severe ascites (ascites up to Child-Pugh score of 3)
- •Biliary perforation
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to enrollment
- •Unstable angina, myocardial infarction, coronary artery bypass graft, congestive heart failure, cerebrovascular accident (including transient ischemic attack, pulmonary embolism) within 3 months before enrollment
- •Persistent arrhythmia (CTCAE criteria grade 2 and above), atrial fibrillation of any degree, prolonged Qtc interval (more than 450 ms in men and more than 470 ms in women)
- •Refractory hypertension (blood pressure above 150/100 mmHg even after optimal drug therapy
- •Concomitant receipt of other anti-tumor drugs
- •Concomitant human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome
- •Pregnant or lactating women
- •Concomitant acute or chronic mental disorders (including mental disorders affecting subject enrollment, therapeutic intervention, and follow-up)
结局指标
主要结局
Overall survival
时间窗: Participants will be followed till die or lost to follow-up, an expected average of a year.
Time from treatment to the day when the patients died or lost to the follow-up.
次要结局
- Quality of life assessed by Quality-of-life Questionnaire Core 30(24 weeks)
- Time to symptom progression(Participants will be followed till progression appeared or die or lost to follow-up, an expected average of a year.)
- Patency(Participants will be followed till die or lost to follow-up, an expected average of a year.)
- Adverse events(Participants will be followed till die or lost to follow-up, an expected average of a year.)
- Relief of jaundice(Relief of jaundice was evaluated within 1 week after stent implantation.)
研究者
Jin-He Guo
Deputy Director, Center of Interventional Radiology & Vascular Surgery
Zhongda Hospital