Phase I/II study of transcatheter arterial chemo-embolization with DDP-H and degradable starch microspheres for hepatic metastases of colorectal cancer

UMIN ID: UMIN000001168

Registered date:02/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colorectal Cancer
• Date of first enrollment: 2008/02/01
• Target sample size: 27
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The protocol in the clinical trial repeatedly makes up treatment couses which is constituted DPP-H and DSM mixing solution injects into hepatic artery until the embolization appears conducts every 4 weeks.

Outcome(s)

• Primary Outcome: Dose Limiting Toxicity,Recommended Dose
• Secondary Outcome: Adverse events, Response rate, Overall survival, Progression free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Reconstruction of the biliary tract history 2) Severe complication (Cardiac failure, Myocardial infarction, Pulmonary fibrosis, Interstitial pneumonia, Uncontrollable diabetic, Renal failure) 3)Active infection (Hepatitis C virus is permitted) 4) Active double cancer 5) Hyper sensitivity history with iodin contrast medium or platinum related substance, or starch 6) Pregnant, nursing or possible pregnant woman 7) Heparic artery occlusion under CT angiography or angiography (Registration after qualification with CT angiography. Judging occlusion under angiography, including reservoir DAS, in case unqualified judgement with CT angiography) 8) Qualified ineligible patients being this clinical trial by responsible doctor

Related Information

• Primary Sponsor: Radiology, Nara Medical University Hospital
• Source(s) of Monetary Support: Radiology, Nara Medical University Hospital