UMIN ID: UMIN000002428
Registered date:14/09/2009
Evaluation of efficacy to combine transarterial chemoembolization and intrahepatic arterial infusion of DDP-H for hepatocellular carcinoma
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Hepatocellular carcinoma |
| Date of first enrollment | 2009/09/01 |
| Target sample size | 160 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | TACE alone TACE + 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 TACE area. 2) Secondary endpoint, allover survival |
|---|---|
| Secondary Outcome | Tumor markers of AFP, DCP and other serum biochemistries. |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| 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 |
|---|---|
| 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 | 025-227-2207 |
| Affiliation | Niigata University Graduate School of Medical and Dental Sciences Department of Gastroenterology & Hepatology |