Study of Adjuvant ONO-4538 With Resected Gastric Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

August 17, 2022

Study Completion Date

March 31, 2023

Conditions
Gastric Cancer
Interventions
DRUG

Nivolumab

Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).

DRUG

Tegafur-gimeracil-oteracil potassium

Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.

DRUG

Capecitabine

Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.

DRUG

Placebo

Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).

Trial Locations (108)

Unknown

Anhui Province Clinical Site, Anhui Province

Beijing Clinical Site1, Beijing

Beijing Clinical Site2, Beijing

Cuangdong Province Clinical Site, Cuangdong Province

Guangdong Province Clinical Site1, Guangdong Province

Guangdong Province Clinical Site2, Guangdong Province

Henan Province Clinical Site1, Henan Province

Henan Province Clinical Site2, Henan Province

Jiangsu Province Clinical Site1, Jiangsu Province

Jiangsu Province Clinical Site3, Jiangsu Province

Jiangsu Province Clinical Site4, Jiangsu Province

Jiangsu Province Clinical Site5, Jiangsu Province

Jiangsu Province Clinical Site6, Jiangsu Province

Jiangxi Province Clinical Site2, Jiangxi Province

Jilin Province Clinical Site, Jilin Province

Liaoning Province Clinical Site, Liaoning Province

Shanxi Province Clinical Site, Shanxi Province

Tianjin Clinical Site1, Tianjin

Tianjin Clinical Site2, Tianjin

Zhejiang Province Clinical Site, Zhejiang Province

Zhengjiang Province Clinical Site, Zhengjiang Province

Aichi Clinical Site1, Nagoya

Aichi Clinical Site2, Nagoya

Chiba Clinical Site, Kamogawa

Ehime Clinical Site, Matsuyama

Ehime Clinicla Site, Matsuyama

Gifu Clinical Site, Ōgaki

Gunma Clinical Site, Ōta

Gunma Clinical Site, Takasaki

Hiroshima Clinical Site, Fukuyama

Hokkaido Clinical Site 3, Hakodate

Hokkaido Clinical Site 1, Sapporo

Hokkaido Clinical Site2, Sapporo

Hyogo Clinical Site, Akashi

Hyogo Clinical Site, Amagasaki

Hyogo Clinical Site, Nishinomiya

Ishikawa Clinical Site, Kanazawa

Iwate Clinical Site, Morioka

Kanagawa Clinical Site, Sagamihara

Kanagawa Clinical Site, Yokohama

Miyagi Clinical Site, Ōsaki

Nagano Clinical Site, Saku

Okayama Clinical Site, Kurashiki

Osaka Clinical Site, Hirakata

Osaka Clinical Site, Ōsaka-sayama

Osaka Clinical Site, Sakai

Osaka Clinical Site, Suita

Osaka Clinical Site, Takatsuki

Osaka Clinical Site, Toyonaka

Saitama Clinical Site, Hidaka

Saitama Clinical Site, Kitaadachi-gun

Shizuoka Clinical Site, Sunto-gun

Tochigi Clinical Site, Shimotsuke

Tokyo Clinical Site, Bunkyo-ku

Tokyo Clinical Site, Chuo-ku

Tokyo Clinical Site, Koto-ku

Tokyo Clinical Site, Shinjuku-ku

Chiba Clinical Site, Chiba

Fukuoka Clinical Site 1, Fukuoka

Fukuoka Clinical Site 2, Fukuoka

Gifu Clinical Site, Gifu

Hiroshima Clinical Site1, Hiroshima

Hiroshima Clinical Site2, Hiroshima

Hiroshima Clinical Site3, Hiroshima

Kochi Clinical Site, Kochi

Kumamoto Clinical Site, Kumamoto

Kyoto Clinical Site, Kyoto

Niigata Clinical Site, Niigata

Osaka Clinical Site1, Osaka

Osaka Clinical Site2, Osaka

Osaka Clinical Site3, Osaka

Osaka Clinical Site4, Osaka

Shizuoka Clinical Site, Shizuoka

Toyama Clinical Site, Toyama

Wakayama Clinical Site, Wakayama

Yamagata Clinical Site, Yamagata

Busan Clinical Site1, Busan

Busan Clinical Site2, Busan

Busan Clinical Site3, Busan

Daegu Clinical Site1, Daegu

Daegu Clinical Site2, Daegu

Daegu Clinical Site3, Daegu

Daejeon Clinical Site 1, Daejeon

Daejeon Clinical Site 2, Daejeon

Gwangju Clinical Site, Gwangju

Gyeonggi-do Clinical Site1, Gyeonggi-do

Gyeonggi-do Clinical Site2, Gyeonggi-do

Gyeonggi-do Clinical Site3, Gyeonggi-do

Gyeonggi-do Clinical Site4, Gyeonggi-do

Gyeonggi-do Clinical Site5, Gyeonggi-do

Jeollabuk-do Clinical Site, Jeollabuk-do

Seoul Clinical Site 8, Seoul

Seoul Clinical Site 9, Seoul

Seoul Clinical Site1, Seoul

Seoul Clinical Site2, Seoul

Seoul Clinical Site3, Seoul

Seoul Clinical Site4, Seoul

Seoul Clinical Site5, Seoul

Seoul Clinical Site6, Seoul

Seoul Clinical Site7, Seoul

Kaohsiung Clinical Site2, Kaohsiung City

Kaohsiung Clinical Site, Kaohsiung City

New Taipei Clinical Site, New Taipei City

Taichung Clinical Site, Taichung

Tainan Clinical Site2, Tainan City

Tainan Clinical Site, Tainan City

Taipei Clinical Site1, Taipei

Taipei Clinical Site2, Taipei

Sponsors
All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Ono Pharmaceutical Co. Ltd

INDUSTRY

NCT03006705 - Study of Adjuvant ONO-4538 With Resected Gastric Cancer | Biotech Hunter | Biotech Hunter