JPRN-jRCTs051200042已完成2 期
Hepatic Arterial Chemoembolization using drug-eluting beads loaded with irinotecan (DEBIRI) for Refractory Colorectal Cancer with Liver Metastases in Japan: A Phase-II Prospective Multicenter Clinical Trial - DEBIRI-Japan
Koichiro Yamakado0 个研究点目标入组 35 人开始时间: 2020年8月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Primary leison with pathologically comfirmed adenocaricinoma of colorectal cancer.
- •(2) Pathologically or clinically confirmed liver metastasis from colorectal cancer.
- •(3) Hypervascular liver metastasis from colorectal cancer refractory for standard chemotherapy and not
- •indicated for surgical resection. Refractory or intolerance or inappropriate for three cytotoxic drugs
- •(fluorinated pyrimidine, irinotecan, oxaliplatin), VEGF inhibitor and EGFR inhibitor.
- •(4) Total volume of liver metastasis less than 50% of the liver. Tumor number and maximum tumor size
- •are not limited. Measurable lesions by RECIST.
- •(5) Extrahepatic metastases are permitted. Key prognostic factor is liver metastasis.
- •(6) Child Pugh score 7 or less than 7 points.
- •(7) ECOG performance 0 or 1
- •(8) 20 years or older
- •(9) The function of main organs (bone marrow, liver and kidney) is well maintained.
- •(10) Written informed consent from the patient
排除标准
- •(1) Tumor thrombus in the main trunk of the potal vein or first branch
- •(2) Past history for surgical biliary reconstruction or endoscopic bile duct treatment.
- •(3) Ascites or pleural effusion refractory for intensive therapy
- •(4) Severe artery-portal vein shunt or artery-venous shunt.
- •(5) Severe stenosis or obstruction of hepatic artery (contrast enhancement CT or MRI or angiography)
- •(6) Past treatment for transcatheter arterial embolization or chemoembolization with microsphere.
- •(7) Following severe complications:
- •1.uncontrolled heart failure, angina, arrhythmia
- •2.myocardial infarction within 6 months
- •3.active infection (excluding viral hepatitis)
- •4.active gastrointestinal bleeding
- •5.hepatic encephalopathy or mental disorder
- •6. hypersensitivity for iodine contrast agent or contrast
- •7. severe drug allergy
- •8. active double cancer (excluding curable early stage cancer)
- •9. pregnancy, lactating state, or patients wishing to become pregnant or have children
- •10. judged to be inapprociate for this study by investigators from the viewpoint of safety
研究者
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