Status:
COMPLETED
Transarterial Chemoembolization by Hepasphere Microspheres for the Treatment of Unresectable Colorectal Liver Metastasis
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Unresectable Colorectal Liver Metastasis
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Colorectal cancer is the third most frequently diagnosed cancer and the third leading cause of cancer related deaths in Taiwan. Of the 10,248 new colorectal patients diagnosed each year approximately ...
Detailed Description
This is an open-label, non-comparative study aimed to evaluate the safety profiles and efficacy of patients with unresectable colorectal liver metastases treated by selective TACE (transarterial chemo...
Eligibility Criteria
Inclusion
- Patients must meet all of the following inclusion criteria in order to be entered into the study:
- Liver dominant metastatic colorectal cancer
- Metastatic colorectal patients who have failed first-line and second-line systemic chemotherapy.
- ECOG 0 to 1 or a Karnofsky Performance score of 80-100%;
- Age 20 years or older
- Patient has signed informed consent
Exclusion
- \- If patients meet any of the following criteria they may not be entered into the study:
- History of severe allergy or intolerance to any contrast media not controlled with premedication
- Severe peripheral vascular disease that would preclude catheterization
- Significant extra-hepatic disease, generally in excess of 50% of the overall whole body tumor bulk outside the liver, or any tumor burden that represented an imminent threat to the patient's life
- Greater than 75% hepatic parenchymal involvement. Previous treatment with any form of transarterial embolization for liver tumors
- f. Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive g. Any contraindication to arteriography or hepatic embolization
Key Trial Info
Start Date :
August 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03264716
Start Date
August 31 2017
End Date
September 11 2018
Last Update
July 15 2019
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan