NCT04912258Unknown3 期
Trans-arterial Chemoembolization With Irinotecan Drug-eluting Beads Before Liver Surgery for Patients With Primary Unresectable Colorectal Liver Metastasis: A Randomized Control Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- liver relapse-free survival
研究概览
简要总结
Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis
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 (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Histologically proven colorectal liver metastasis；
- •With liver-dominant disease；
- •Primarily evaluated as potentially resectable and conversed successfully
- •Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3 (within 1 week prior to randomization)
- •Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl (within 1 week prior to randomization);
- •Written informed consent for participation in the trial.
排除标准
- •Primarily evaluated as resectable
- •Failed to converse
- •Patients with known hypersensitivity reactions to any of the components of the study treatments.
- •Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- •Other previous malignancy within 5 years
- •Known drug abuse/ alcohol abuse
- •Legal incapacity or limited legal capacity
研究组 & 干预措施
Arm A
Experimental
DEB-TACE before liver surgery
干预措施: Trans arterial chemoembolization with Irinotecan Drug-eluting Beads (Drug)
结局指标
主要结局
liver relapse-free survival
时间窗: 6 months
from liver surgery to liver relapse
次要结局
- response rate(2 months)
- relapse-free survival(6 months)
- overall survival(12 months)
研究者
研究点 (1)
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