UMIN ID: UMIN000002427
Registered date:14/09/2009
Evaluation of efficacy to combine radiofrequency ablation therapy and intrahepatic arterial infusion of DDP-H for hepatocellular carcinoma
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Hepatocellular carcinoma |
Date of first enrollment | 2009/09/01 |
Target sample size | 120 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Radiofrequency ablation therapy Radiofrequency ablation therapy + intrahepatic arterial infusion of DDP-H |
Outcome(s)
Primary Outcome | 1) Primary endpoint, the time when a classical HCC is confirmed by several imaging modalities in the liver except for the vicinity to the RFA area. 2) Secondary endpoint, allover survival |
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Secondary Outcome | Tumor markers of AFP, DCP and other serum biochemistries. |
Key inclusion & exclusion criteria
Age minimum | 15years-old |
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Age maximum | 80years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) Severe allergic history for iodine and platinum drug 2) Pregnant, possibility of pregnancy, or feeding a baby 3) Vascular involvement Vp3, Vv3 or more 4) Under interferon therapy 5) Other factors that a responsible doctor judged to be unsuitable |
Related Information
Primary Sponsor | Niigata Hepatocellular Carcinoma Therapy Study Group |
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Secondary Sponsor | |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Akihiko Ohsaki |
Address | 1-757 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan Japan |
Telephone | 025-227-2207 |
tm98020ao-nii@umin.ac.jp | |
Affiliation | Niigata Hepatocellular Carcinoma Therapy Study Group Excutive office |
scientific contact | |
Name | Takeshi Suda |
Address | 1-754 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan Japan |
Telephone | 025-223-6161 |
tspitt@med.niigata-u.ac.jp | |
Affiliation | Niigata University Graduate School of Medical and Dental Sciences Department of Gastroenterology & Hepatology |