NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051200042

Registered date:11/08/2020

DEBIRI

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedliver metastasis from colorectal cancer
Date of first enrollment20/08/2020
Target sample size35
Countries of recruitment
Study typeInterventional
Intervention(s)Hepatic Arterial Chemoembolization using drug-eluting beads loaded with irinotecan (DEBIRI) for Refractory Colorectal Cancer with Liver Metastases.

Outcome(s)

Primary Outcomeliver-specific progression-free survival
Secondary Outcomeoverall survival, progression-free survival, response rate, adverse event rate

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria(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
Exclude criteria(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

Related Information

Contact

Public contact
Name Ogasawara Atsushi
Address 1-1 Mukogawa, Nishinomiya-city, Hyogo, Japan Hyogo Japan 663-8501
Telephone +81-798-45-6362
E-mail at-ogasawara@hyo-med.ac.jp
Affiliation Hyogo Medical University Hospital
Scientific contact
Name Yamakado Koichiro
Address 1-1 Mukogawa, Nishinomiya-city, Hyogo, Japan Hyogo Japan 663-8501
Telephone +81-798-45-6362
E-mail yamakado47@gmail.com
Affiliation Hyogo Medical University Hospital