Study of Adjuvant ONO-4538 With Resected Gastric Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Nivolumab group 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. |
Drug: Nivolumab
Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Other Names:
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.
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Placebo Comparator: Placebo group 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. |
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).
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Outcome Measures
Primary Outcome Measures
- Relapse-free survival (RFS) [5 years]
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with histologically confirmed adenocarcinoma of the stomach
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Patients without a remnant cancer (R0) who have undergone gastrectomy
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Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings
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Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
Exclusion Criteria:
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Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer
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Multiple primary cancers
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A current or past history of severe hypersensitivity to any other antibody products
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Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Anhui Province Clinical Site | Anhui Province | China | ||
2 | Beijing Clinical Site1 | Beijing | China | ||
3 | Beijing Clinical Site2 | Beijing | China | ||
4 | Cuangdong Province Clinical Site | Cuangdong Province | China | ||
5 | Guangdong Province Clinical Site1 | Guangdong Province | China | ||
6 | Guangdong Province Clinical Site2 | Guangdong Province | China | ||
7 | Henan Province Clinical Site1 | Henan Province | China | ||
8 | Henan Province Clinical Site2 | Henan Province | China | ||
9 | Jiangsu Province Clinical Site1 | Jiangsu Province | China | ||
10 | Jiangsu Province Clinical Site3 | Jiangsu Province | China | ||
11 | Jiangsu Province Clinical Site4 | Jiangsu Province | China | ||
12 | Jiangsu Province Clinical Site5 | Jiangsu Province | China | ||
13 | Jiangsu Province Clinical Site6 | Jiangsu Province | China | ||
14 | Jiangxi Province Clinical Site2 | Jiangxi Province | China | ||
15 | Jilin Province Clinical Site | Jilin Province | China | ||
16 | Liaoning Province Clinical Site | Liaoning Province | China | ||
17 | Shanxi Province Clinical Site | Shanxi Province | China | ||
18 | Tianjin Clinical Site1 | Tianjin | China | ||
19 | Tianjin Clinical Site2 | Tianjin | China | ||
20 | Zhejiang Province Clinical Site | Zhejiang Province | China | ||
21 | Zhengjiang Province Clinical Site | Zhengjiang Province | China | ||
22 | Aichi Clinical Site1 | Nagoya | Aichi | Japan | |
23 | Aichi Clinical Site2 | Nagoya | Aichi | Japan | |
24 | Chiba Clinical Site | Kamogawa | Chiba | Japan | |
25 | Ehime Clinical Site | Matsuyama | Ehime | Japan | |
26 | Ehime Clinicla Site | Matsuyama | Ehime | Japan | |
27 | Gifu Clinical Site | Ōgaki | Gifu | Japan | |
28 | Gunma Clinical Site | Ota | Gunma | Japan | |
29 | Gunma Clinical Site | Takasaki | Gunma | Japan | |
30 | Hiroshima Clinical Site | Fukuyama | Hiroshima | Japan | |
31 | Hokkaido Clinical Site 3 | Hakodate | Hokkaido | Japan | |
32 | Hokkaido Clinical Site 1 | Sapporo | Hokkaido | Japan | |
33 | Hokkaido Clinical Site2 | Sapporo | Hokkaido | Japan | |
34 | Hyogo Clinical Site | Akashi | Hyogo | Japan | |
35 | Hyogo Clinical Site | Amagasaki | Hyogo | Japan | |
36 | Hyogo Clinical Site | Nishinomiya | Hyogo | Japan | |
37 | Ishikawa Clinical Site | Kanazawa | Ishikawa | Japan | |
38 | Iwate Clinical Site | Morioka | Iwate | Japan | |
39 | Kanagawa Clinical Site | Sagamihara | Kanagawa | Japan | |
40 | Kanagawa Clinical Site | Yokohama | Kanagawa | Japan | |
41 | Miyagi Clinical Site | Osaki | Miyagi | Japan | |
42 | Nagano Clinical Site | Saku | Nagano | Japan | |
43 | Okayama Clinical Site | Kurashiki | Okayama | Japan | |
44 | Osaka Clinical Site | Hirakata | Osaka | Japan | |
45 | Osaka Clinical Site | Sakai | Osaka | Japan | |
46 | Osaka Clinical Site | Suita | Osaka | Japan | |
47 | Osaka Clinical Site | Takatsuki | Osaka | Japan | |
48 | Osaka Clinical Site | Toyonaka | Osaka | Japan | |
49 | Osaka Clinical Site | Ōsaka-sayama | Osaka | Japan | |
50 | Saitama Clinical Site | Hidaka | Saitama | Japan | |
51 | Saitama Clinical Site | Kitaadachi-gun | Saitama | Japan | |
52 | Shizuoka Clinical Site | Sunto-gun | Shizuoka | Japan | |
53 | Tochigi Clinical Site | Shimotsuke | Tochigi | Japan | |
54 | Tokyo Clinical Site | Bunkyo-ku | Tokyo | Japan | |
55 | Tokyo Clinical Site | Chuo-ku | Tokyo | Japan | |
56 | Tokyo Clinical Site | Koto-ku | Tokyo | Japan | |
57 | Tokyo Clinical Site | Shinjuku-ku | Tokyo | Japan | |
58 | Chiba Clinical Site | Chiba | Japan | ||
59 | Fukuoka Clinical Site 1 | Fukuoka | Japan | ||
60 | Fukuoka Clinical Site 2 | Fukuoka | Japan | ||
61 | Gifu Clinical Site | Gifu | Japan | ||
62 | Hiroshima Clinical Site1 | Hiroshima | Japan | ||
63 | Hiroshima Clinical Site2 | Hiroshima | Japan | ||
64 | Hiroshima Clinical Site3 | Hiroshima | Japan | ||
65 | Kochi Clinical Site | Kochi | Japan | ||
66 | Kumamoto Clinical Site | Kumamoto | Japan | ||
67 | Kyoto Clinical Site | Kyoto | Japan | ||
68 | Niigata Clinical Site | Niigata | Japan | ||
69 | Osaka Clinical Site1 | Osaka | Japan | ||
70 | Osaka Clinical Site2 | Osaka | Japan | ||
71 | Osaka Clinical Site3 | Osaka | Japan | ||
72 | Osaka Clinical Site4 | Osaka | Japan | ||
73 | Shizuoka Clinical Site | Shizuoka | Japan | ||
74 | Toyama Clinical Site | Toyama | Japan | ||
75 | Wakayama Clinical Site | Wakayama | Japan | ||
76 | Yamagata Clinical Site | Yamagata | Japan | ||
77 | Busan Clinical Site1 | Busan | Korea, Republic of | ||
78 | Busan Clinical Site2 | Busan | Korea, Republic of | ||
79 | Busan Clinical Site3 | Busan | Korea, Republic of | ||
80 | Daegu Clinical Site1 | Daegu | Korea, Republic of | ||
81 | Daegu Clinical Site2 | Daegu | Korea, Republic of | ||
82 | Daegu Clinical Site3 | Daegu | Korea, Republic of | ||
83 | Daejeon Clinical Site 1 | Daejeon | Korea, Republic of | ||
84 | Daejeon Clinical Site 2 | Daejeon | Korea, Republic of | ||
85 | Gwangju Clinical Site | Gwangju | Korea, Republic of | ||
86 | Gyeonggi-do Clinical Site1 | Gyeonggi-do | Korea, Republic of | ||
87 | Gyeonggi-do Clinical Site2 | Gyeonggi-do | Korea, Republic of | ||
88 | Gyeonggi-do Clinical Site3 | Gyeonggi-do | Korea, Republic of | ||
89 | Gyeonggi-do Clinical Site4 | Gyeonggi-do | Korea, Republic of | ||
90 | Gyeonggi-do Clinical Site5 | Gyeonggi-do | Korea, Republic of | ||
91 | Jeollabuk-do Clinical Site | Jeollabuk-do | Korea, Republic of | ||
92 | Seoul Clinical Site 8 | Seoul | Korea, Republic of | ||
93 | Seoul Clinical Site 9 | Seoul | Korea, Republic of | ||
94 | Seoul Clinical Site1 | Seoul | Korea, Republic of | ||
95 | Seoul Clinical Site2 | Seoul | Korea, Republic of | ||
96 | Seoul Clinical Site3 | Seoul | Korea, Republic of | ||
97 | Seoul Clinical Site4 | Seoul | Korea, Republic of | ||
98 | Seoul Clinical Site5 | Seoul | Korea, Republic of | ||
99 | Seoul Clinical Site6 | Seoul | Korea, Republic of | ||
100 | Seoul Clinical Site7 | Seoul | Korea, Republic of | ||
101 | Kaohsiung Clinical Site2 | Kaohsiung | Taiwan | ||
102 | Kaohsiung Clinical Site | Kaohsiung | Taiwan | ||
103 | New Taipei Clinical Site | New Taipei | Taiwan | ||
104 | Taichung Clinical Site | Taichung | Taiwan | ||
105 | Tainan Clinical Site2 | Tainan | Taiwan | ||
106 | Tainan Clinical Site | Tainan | Taiwan | ||
107 | Taipei Clinical Site1 | Taipei | Taiwan | ||
108 | Taipei Clinical Site2 | Taipei | Taiwan |
Sponsors and Collaborators
- Ono Pharmaceutical Co. Ltd
- Bristol-Myers Squibb
Investigators
- Study Director: Mitsunobu Tanimoto, Ono Pharmaceutical Co. Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ONO-4538-38