Study of Adjuvant ONO-4538 With Resected Gastric Cancer
- Conditions
- Gastric Cancer
- Interventions
- Registration Number
- NCT03006705
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nivolumab group Tegafur-gimeracil-oteracil potassium Nivolumab: 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 Placebo: 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. Placebo group Tegafur-gimeracil-oteracil potassium Placebo: 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. Nivolumab group Nivolumab Nivolumab: 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. Nivolumab group Oxaliplatin Nivolumab: 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 Oxaliplatin Placebo: 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. Nivolumab group Capecitabine Nivolumab: 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 Capecitabine Placebo: 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.
- Primary Outcome Measures
Name Time Method Relapse-free survival (RFS) 5 years
- Secondary Outcome Measures
Name Time Method 5-year RFS rate 5 years 3-year RFS rate 3 years Overall survival (OS) 5 years 3-year OS rate 3 years 5-year OS rate 5 years Safety will be analyzed through the incidence of adverse events, serious adverse events Up to 28 days from last dose Safety will be analyzed through the incidence of laboratory abnormalities Up to 28 days from last dose
Trial Locations
- Locations (92)
Anhui Province Clinical Site
🇨🇳Anhui Province, China
Zhejiang Province Clinical Site
🇨🇳Zhejiang Province, China
Nagano Clinical Site
🇯🇵Saku, Nagano, Japan
Kochi Clinical Site
🇯🇵Kochi, Japan
Jiangsu Province Clinical Site1
🇨🇳Jiangsu Province, China
Jiangsu Province Clinical Site6
🇨🇳Jiangsu Province, China
Shanxi Province Clinical Site
🇨🇳Shanxi Province, China
Zhengjiang Province Clinical Site
🇨🇳Zhengjiang Province, China
Jiangsu Province Clinical Site4
🇨🇳Jiangsu Province, China
Liaoning Province Clinical Site
🇨🇳Liaoning Province, China
Tianjin Clinical Site1
🇨🇳Tianjin, China
Tianjin Clinical Site2
🇨🇳Tianjin, China
Aichi Clinical Site2
🇯🇵Nagoya, Aichi, Japan
Osaka Clinical Site
🇯🇵Ōsaka-sayama, Osaka, Japan
Tochigi Clinical Site
🇯🇵Shimotsuke, Tochigi, Japan
Osaka Clinical Site2
🇯🇵Osaka, Japan
Seoul Clinical Site3
🇰🇷Seoul, Korea, Republic of
Daegu Clinical Site3
🇰🇷Daegu, Korea, Republic of
Daejeon Clinical Site 1
🇰🇷Daejeon, Korea, Republic of
Busan Clinical Site3
🇰🇷Busan, Korea, Republic of
Gyeonggi-do Clinical Site2
🇰🇷Gyeonggi-do, Korea, Republic of
Gwangju Clinical Site
🇰🇷Gwangju, Korea, Republic of
Gyeonggi-do Clinical Site3
🇰🇷Gyeonggi-do, Korea, Republic of
Gyeonggi-do Clinical Site4
🇰🇷Gyeonggi-do, Korea, Republic of
Taichung Clinical Site
🇨🇳Taichung, Taiwan
Taipei Clinical Site2
🇨🇳Taipei, Taiwan
Seoul Clinical Site6
🇰🇷Seoul, Korea, Republic of
Tainan Clinical Site
🇨🇳Tainan, Taiwan
Taipei Clinical Site1
🇨🇳Taipei, Taiwan
Jeollabuk-do Clinical Site
🇰🇷Jeollabuk-do, Korea, Republic of
Daegu Clinical Site1
🇰🇷Daegu, Korea, Republic of
Seoul Clinical Site1
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site7
🇰🇷Seoul, Korea, Republic of
Guangdong Province Clinical Site2
🇨🇳Guangdong 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
Henan Province Clinical Site1
🇨🇳Henan Province, China
Henan Province Clinical Site2
🇨🇳Henan Province, China
Jiangsu Province Clinical Site3
🇨🇳Jiangsu Province, China
Jiangsu Province Clinical Site5
🇨🇳Jiangsu Province, China
Jilin Province Clinical Site
🇨🇳Jilin Province, China
Jiangxi Province Clinical Site2
🇨🇳Jiangxi Province, China
Chiba Clinical Site
🇯🇵Chiba, Japan
Hyogo Clinical Site
🇯🇵Nishinomiya, Hyogo, Japan
Hokkaido Clinical Site 3
🇯🇵Hakodate, Hokkaido, Japan
Ishikawa Clinical Site
🇯🇵Kanazawa, Ishikawa, Japan
Gunma Clinical Site
🇯🇵Takasaki, Gunma, Japan
Hokkaido Clinical Site 1
🇯🇵Sapporo, Hokkaido, Japan
Saitama Clinical Site
🇯🇵Kitaadachi-gun, Saitama, Japan
Hiroshima Clinical Site1
🇯🇵Hiroshima, Japan
Busan Clinical Site2
🇰🇷Busan, Korea, Republic of
Busan Clinical Site1
🇰🇷Busan, Korea, Republic of
Daegu Clinical Site2
🇰🇷Daegu, Korea, Republic of
Daejeon Clinical Site 2
🇰🇷Daejeon, Korea, Republic of
Gyeonggi-do Clinical Site1
🇰🇷Gyeonggi-do, Korea, Republic of
Gyeonggi-do Clinical Site5
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul Clinical Site 8
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site2
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site4
🇰🇷Seoul, Korea, Republic of
Kaohsiung Clinical Site
🇨🇳Kaohsiung, Taiwan
New Taipei Clinical Site
🇨🇳New Taipei, Taiwan
Seoul Clinical Site 9
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site5
🇰🇷Seoul, Korea, Republic of
Ehime Clinicla Site
🇯🇵Matsuyama, Ehime, Japan
Hiroshima Clinical Site
🇯🇵Fukuyama, Hiroshima, Japan
Iwate Clinical Site
🇯🇵Morioka, Iwate, Japan
Ehime Clinical Site
🇯🇵Matsuyama, Ehime, Japan
Gifu Clinical Site
🇯🇵Gifu, Japan
Okayama Clinical Site
🇯🇵Kurashiki, Okayama, Japan
Kumamoto Clinical Site
🇯🇵Kumamoto, Japan
Shizuoka Clinical Site
🇯🇵Shizuoka, Japan
Hiroshima Clinical Site2
🇯🇵Hiroshima, Japan
Hokkaido Clinical Site2
🇯🇵Sapporo, Hokkaido, Japan
Kanagawa Clinical Site
🇯🇵Yokohama, Kanagawa, Japan
Fukuoka Clinical Site 2
🇯🇵Fukuoka, Japan
Kyoto Clinical Site
🇯🇵Kyoto, Japan
Niigata Clinical Site
🇯🇵Niigata, Japan
Osaka Clinical Site1
🇯🇵Osaka, Japan
Osaka Clinical Site3
🇯🇵Osaka, Japan
Osaka Clinical Site4
🇯🇵Osaka, Japan
Toyama Clinical Site
🇯🇵Toyama, Japan
Yamagata Clinical Site
🇯🇵Yamagata, Japan
Tokyo Clinical Site
🇯🇵Shinjuku-ku, Tokyo, Japan
Aichi Clinical Site1
🇯🇵Nagoya, Aichi, Japan
Miyagi Clinical Site
🇯🇵Osaki, Miyagi, Japan
Fukuoka Clinical Site 1
🇯🇵Fukuoka, Japan
Wakayama Clinical Site
🇯🇵Wakayama, Japan
Kaohsiung Clinical Site2
🇨🇳Kaohsiung, Taiwan
Tainan Clinical Site2
🇨🇳Tainan, Taiwan
Hiroshima Clinical Site3
🇯🇵Hiroshima, Japan