DEBIRI

JRCT ID: jRCTs051200042

Registered date:11/08/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: liver metastasis from colorectal cancer
• Date of first enrollment: 11/08/2020
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Hepatic Arterial Chemoembolization using drug-eluting beads loaded with irinotecan (DEBIRI) for Refractory Colorectal Cancer with Liver Metastases.

Outcome(s)

• Primary Outcome: liver-specific progression-free survival
• Secondary Outcome: overall survival, progression-free survival, response rate, adverse event rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Koichiro Yamakado
• Secondary ID(s): Nil known