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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000020798 |
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Date of registration:
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29/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety trial of ECI301 for hepatocellular carcinoma patient treated with radio frequency ablation
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Scientific title:
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Safety trial of ECI301 for hepatocellular carcinoma patient treated with radio frequency ablation - Safety trial of ECI301 for hepatocellular carcinoma patient treated with radio frequency ablation |
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Date of first enrolment:
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2013/02/01 |
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Target sample size:
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9 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024011 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Shuichi Kaneko |
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Address:
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13-1 Takara-machi, Kanazawa, Ishikawa
Japan |
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Telephone:
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076-265-2235 |
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Email:
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niken@m-kanazawa.jp |
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Affiliation:
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Kanazawa University Hospital Department of gastroenterology |
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Name:
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Noriho Iida |
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Address:
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13-1 Takara-machi, Kanazawa, Ishikawa
Japan |
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Telephone:
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076-265-2235 |
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Email:
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niida@m-kanazawa.jp |
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Affiliation:
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Kanazawa University Hospital Department of gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients who have severe disease in heart, kidnet, lung, hematopoiesis, coagulation system are excluded. Peatients who undego surgery, TACE, chmotherapy and radiation therapy within 4 weeks before the entry are excluded.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Hepatocellular carcinoma patinets
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Intervention(s)
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ECI301 (50, 100, or 150 microg/kg BW) will be injected daily for 5 days immediately after radio-frequency ablation treatment
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Primary Outcome(s)
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Safety of ECI301 for hapatocelluar carcinoma patients treated with radio-frequency ablation will be assessed in 4 weeks after the treatment according to CTCAE
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Source(s) of Monetary Support
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Kanazawa University
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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02/11/2018 |
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URL:
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