Journal
FUTURE ONCOLOGY
Volume 15, Issue 21, Pages 2441-2447Publisher
FUTURE MEDICINE LTD
DOI: 10.2217/fon-2019-0167
Keywords
gastric cancer; gut microbiome; nivolumab; predictive marker
Categories
Funding
- Ono Pharmaceutical
- Bristol-Myers Squibb
- Japan Clinical Cancer Research Organization (JACCRO)
- Daiichi Sankyo Co. Ltd
- Eisai Co. Ltd
- Dainippon Sumitomo Pharmaceutical Co. Ltd
- Nippon Kayaku Pharmaceutical Co. Ltd
- MSD KK
- Ono Pharmaceutical Co. Ltd
- Eli Lilly Japan KK
- Merck Serono
- Taiho Pharmaceutical Co. Ltd
- Takeda Pharmaceutical Co. Ltd
- Chugai Pharmaceutical Co. Ltd
- Sanofi KK
- Solasia Pharma KK
- Daiichi Sankyo Pharmaceutical Co. Ltd
- Shionogi Co. Ltd
- Kyowa Hakko Kirin Pharmaceutical Co. Ltd
- Gilead Sciences
- Pfizer
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Aim: Nivolumab has survival benefit in patients with previously treated advanced gastric cancer; however, about 60% of the patients did not respond to nivolumab, raising the necessity of its predictive biomarkers. Gut microbiome has been shown to be associated with efficacy of anti-PD-1 antibody in various types of cancers, but little is known about gastric cancer. Design: This is an observational/translational study to evaluate clinical outcomes of nivolumab and to discover novel immune-related biomarkers (gut microbiome, genetic polymorphism, gene expression and metabolome in plasma) in gastric cancer, using fecal and blood samples at two points before and after treatment. Candidate factors will be explored in first 200 patients and then validated in last 300 patients. Trial registration: UMIN000030850.
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