Study of Adjuvant ONO-4538 With Resected Gastric Cancer
A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy
1 other identifier
interventional
800
4 countries
108
Brief Summary
The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Jan 2017
Typical duration for phase_3 gastric-cancer
108 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2016
CompletedFirst Posted
Study publicly available on registry
December 30, 2016
CompletedStudy Start
First participant enrolled
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedMay 3, 2024
May 1, 2024
5.5 years
December 27, 2016
May 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse-free survival (RFS)
5 years
Secondary Outcomes (7)
Overall survival (OS)
5 years
3-year OS rate
3 years
5-year OS rate
5 years
3-year RFS rate
3 years
5-year RFS rate
5 years
- +2 more secondary outcomes
Study Arms (2)
Nivolumab group
EXPERIMENTALNivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year). Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator. S-1 therapy(maximum 1 year): Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off CapeOX Therapy(maximum 6 months): Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
Placebo group
PLACEBO COMPARATORPlacebo: Placebo solution intravenously for 30 min in every 3 weeks (maximum 1 year). Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator. S-1 therapy(maximum 1 year): Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off CapeOX Therapy(maximum 6 months): Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
Interventions
Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Eligibility Criteria
You may qualify if:
- Patients with histologically confirmed adenocarcinoma of the stomach
- Patients without a remnant cancer (R0) who have undergone gastrectomy
- Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
You may not qualify if:
- Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer
- Multiple primary cancers
- A current or past history of severe hypersensitivity to any other antibody products
- Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ono Pharmaceutical Co. Ltdlead
- Bristol-Myers Squibbcollaborator
Study Sites (108)
Anhui Province Clinical Site
Anhui Province, China
Beijing Clinical Site1
Beijing, China
Beijing Clinical Site2
Beijing, China
Cuangdong Province Clinical Site
Cuangdong Province, China
Guangdong Province Clinical Site1
Guangdong Province, China
Guangdong Province Clinical Site2
Guangdong Province, China
Henan Province Clinical Site1
Henan Province, China
Henan Province Clinical Site2
Henan Province, China
Jiangsu Province Clinical Site1
Jiangsu Province, China
Jiangsu Province Clinical Site3
Jiangsu Province, China
Jiangsu Province Clinical Site4
Jiangsu Province, China
Jiangsu Province Clinical Site5
Jiangsu Province, China
Jiangsu Province Clinical Site6
Jiangsu Province, China
Jiangxi Province Clinical Site2
Jiangxi Province, China
Jilin Province Clinical Site
Jilin Province, China
Liaoning Province Clinical Site
Liaoning Province, China
Shanxi Province Clinical Site
Shanxi Province, China
Tianjin Clinical Site1
Tianjin, China
Tianjin Clinical Site2
Tianjin, China
Zhejiang Province Clinical Site
Zhejiang Province, China
Zhengjiang Province Clinical Site
Zhengjiang Province, China
Aichi Clinical Site1
Nagoya, Aichi-ken, Japan
Aichi Clinical Site2
Nagoya, Aichi-ken, Japan
Chiba Clinical Site
Kamogawa, Chiba, Japan
Ehime Clinical Site
Matsuyama, Ehime, Japan
Ehime Clinicla Site
Matsuyama, Ehime, Japan
Gifu Clinical Site
Ōgaki, Gifu, Japan
Gunma Clinical Site
Ōta, Gunma, Japan
Gunma Clinical Site
Takasaki, Gunma, Japan
Hiroshima Clinical Site
Fukuyama, Hiroshima, Japan
Hokkaido Clinical Site 3
Hakodate, Hokkaido, Japan
Hokkaido Clinical Site 1
Sapporo, Hokkaido, Japan
Hokkaido Clinical Site2
Sapporo, Hokkaido, Japan
Hyogo Clinical Site
Akashi, Hyōgo, Japan
Hyogo Clinical Site
Amagasaki, Hyōgo, Japan
Hyogo Clinical Site
Nishinomiya, Hyōgo, Japan
Ishikawa Clinical Site
Kanazawa, Ishikawa-ken, Japan
Iwate Clinical Site
Morioka, Iwate, Japan
Kanagawa Clinical Site
Sagamihara, Kanagawa, Japan
Kanagawa Clinical Site
Yokohama, Kanagawa, Japan
Miyagi Clinical Site
Ōsaki, Miyagi, Japan
Nagano Clinical Site
Saku, Nagano, Japan
Okayama Clinical Site
Kurashiki, Okayama-ken, Japan
Osaka Clinical Site
Hirakata, Osaka, Japan
Osaka Clinical Site
Ōsaka-sayama, Osaka, Japan
Osaka Clinical Site
Sakai, Osaka, Japan
Osaka Clinical Site
Suita, Osaka, Japan
Osaka Clinical Site
Takatsuki, Osaka, Japan
Osaka Clinical Site
Toyonaka, Osaka, Japan
Saitama Clinical Site
Hidaka, Saitama, Japan
Saitama Clinical Site
Kitaadachi-gun, Saitama, Japan
Shizuoka Clinical Site
Sunto-gun, Shizuoka, Japan
Tochigi Clinical Site
Shimotsuke, Tochigi, Japan
Tokyo Clinical Site
Bunkyo-ku, Tokyo, Japan
Tokyo Clinical Site
Chuo-ku, Tokyo, Japan
Tokyo Clinical Site
Koto-ku, Tokyo, Japan
Tokyo Clinical Site
Shinjuku-ku, Tokyo, Japan
Chiba Clinical Site
Chiba, Japan
Fukuoka Clinical Site 1
Fukuoka, Japan
Fukuoka Clinical Site 2
Fukuoka, Japan
Gifu Clinical Site
Gifu, Japan
Hiroshima Clinical Site1
Hiroshima, Japan
Hiroshima Clinical Site2
Hiroshima, Japan
Hiroshima Clinical Site3
Hiroshima, Japan
Kochi Clinical Site
Kochi, Japan
Kumamoto Clinical Site
Kumamoto, Japan
Kyoto Clinical Site
Kyoto, Japan
Niigata Clinical Site
Niigata, Japan
Osaka Clinical Site1
Osaka, Japan
Osaka Clinical Site2
Osaka, Japan
Osaka Clinical Site3
Osaka, Japan
Osaka Clinical Site4
Osaka, Japan
Shizuoka Clinical Site
Shizuoka, Japan
Toyama Clinical Site
Toyama, Japan
Wakayama Clinical Site
Wakayama, Japan
Yamagata Clinical Site
Yamagata, Japan
Busan Clinical Site1
Busan, South Korea
Busan Clinical Site2
Busan, South Korea
Busan Clinical Site3
Busan, South Korea
Daegu Clinical Site1
Daegu, South Korea
Daegu Clinical Site2
Daegu, South Korea
Daegu Clinical Site3
Daegu, South Korea
Daejeon Clinical Site 1
Daejeon, South Korea
Daejeon Clinical Site 2
Daejeon, South Korea
Gwangju Clinical Site
Gwangju, South Korea
Gyeonggi-do Clinical Site1
Gyeonggi-do, South Korea
Gyeonggi-do Clinical Site2
Gyeonggi-do, South Korea
Gyeonggi-do Clinical Site3
Gyeonggi-do, South Korea
Gyeonggi-do Clinical Site4
Gyeonggi-do, South Korea
Gyeonggi-do Clinical Site5
Gyeonggi-do, South Korea
Jeollabuk-do Clinical Site
Jeollabuk-do, South Korea
Seoul Clinical Site 8
Seoul, South Korea
Seoul Clinical Site 9
Seoul, South Korea
Seoul Clinical Site1
Seoul, South Korea
Seoul Clinical Site2
Seoul, South Korea
Seoul Clinical Site3
Seoul, South Korea
Seoul Clinical Site4
Seoul, South Korea
Seoul Clinical Site5
Seoul, South Korea
Seoul Clinical Site6
Seoul, South Korea
Seoul Clinical Site7
Seoul, South Korea
Kaohsiung Clinical Site2
Kaohsiung City, Taiwan
Kaohsiung Clinical Site
Kaohsiung City, Taiwan
New Taipei Clinical Site
New Taipei City, Taiwan
Taichung Clinical Site
Taichung, Taiwan
Tainan Clinical Site2
Tainan, Taiwan
Tainan Clinical Site
Tainan, Taiwan
Taipei Clinical Site1
Taipei, Taiwan
Taipei Clinical Site2
Taipei, Taiwan
Related Publications (2)
Kang YK, Terashima M, Kim YW, Boku N, Chung HC, Chen JS, Ji J, Yeh TS, Chen LT, Ryu MH, Kim JG, Omori T, Rha SY, Kim TY, Ryu KW, Sakuramoto S, Nishida Y, Fukushima N, Yamada T, Bai LY, Hirashima Y, Hagihara S, Nakada T, Sasako M. Adjuvant nivolumab plus chemotherapy versus placebo plus chemotherapy for stage III gastric or gastro-oesophageal junction cancer after gastrectomy with D2 or more extensive lymph-node dissection (ATTRACTION-5): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Aug;9(8):705-717. doi: 10.1016/S2468-1253(24)00156-0. Epub 2024 Jun 18.
PMID: 38906161DERIVEDChang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
PMID: 35623069DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2016
First Posted
December 30, 2016
Study Start
January 31, 2017
Primary Completion
August 17, 2022
Study Completion
March 31, 2023
Last Updated
May 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share