UMIN ID: UMIN000032686
Registered date:24/05/2018
A Biomarker Analysis of Nivolumab in Previously Treated Advanced Gastric Cancer(WJOG10417GTR)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Gastric Cancer |
| Date of first enrollment | 2018/07/02 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | To explore the factors related of efficacy of nivolumab such as response, progression free survival and overall survival |
|---|---|
| Secondary Outcome | To explore the mechanism of intrinsic and acquired resistance of nivolumab |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Synchronous or metachronous malignancies 2) A positive test result for any of the followings: Human immunodeficiency virus antibody, hepatitis B surfaces (HBs) antigen, or hepatitis C virus antibody 3) Positive test result for either HBs antibody or hepatitis B core antibody, with a detectable level of hepatitis B virus-deoxyribonucleic acid (HBV-DNA) even in case of negative HBs antigen test 4) Judged to be incapable of providing consent for certain reasons, such as concurrent dementia |
Related Information
| Primary Sponsor | West Japan Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | ONO PHARMACEUTICAL CO., LTD. and Bristol-Myers Squibb K.K. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shinichiro Nakamura |
| Address | Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN Japan |
| Telephone | 06-6633-7400 |
| datacenter@wjog.jp | |
| Affiliation | West Japan Oncology Group WJOG datacenter |
| scientific contact | |
| Name | Narikazu Boku |
| Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan Japan |
| Telephone | 03-3542-2511 |
| nboku@ncc.go.jp | |
| Affiliation | National Cancer Center Hospital Gastrointestinal Medical Oncology Division |