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

Phase 1

• Conditions: Colorectal Cancer

• Registration Number: JPRN-UMIN000001168
• Lead Sponsor: Radiology, Nara Medical University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-02
• Study Completion: 2010-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity,Recommended Dose

Secondary Outcome Measures

Name	Time	Method
Adverse events, Response rate, Overall survival, Progression free survival