UMIN ID: UMIN000001417
Registered date:08/10/2008
The efficacy and safety of autologous gamma/delta T cell transfer therapy after resection of intrahepatic cholangiocarcinoma or biliary tract cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Intrahepatic cholangiocarcinoma biliary tract cancer |
| Date of first enrollment | 2008/09/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Gamma/delta T cells are injected on day0, day14, day28, day42, day56, day70, day84, day98. Gemcitabine on day-3, day4, day11, day25, day32, day39, day53, day60, day67, day81, day88, day95. |
Outcome(s)
| Primary Outcome | Relapse free survival Recurrence rate (1 and 2 years) |
|---|---|
| Secondary Outcome | Overall survival Response rate Survival rate (3 and 5 years) Response of tumor-related markers Immunological responses Safety |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients who have: - Pulmonary fibrosis or interstitial pneumonia, or history or predisposition of them; - Active enteritis; - Active autoimmune diseases; - Active infections; - Other cancers; - Other serious complications; - Continuous systemic administration of steroids. |
Related Information
| Primary Sponsor | The University of Tokyo Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Medinet Co.,Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazuhiro Kakimi |
| Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan Japan |
| Telephone | 03-5805-3161 |
| immunotherapy-admin@umin.ac.jp | |
| Affiliation | Graduate School of Medicine, The University of Tokyo Department of Immunotherapeutics |
| scientific contact | |
| Name | Norihiro Kokudo |
| Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan Japan |
| Telephone | 03-5800-8654 |
| Affiliation | The University of Tokyo Hospital Department of Hepatobiliary Pancreatic Surgery and Department of Artificial Organ and Transplantation Surgery |