Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab group | Experimental | 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 Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival (RFS) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 5 years | |
| 3-year OS rate | 3 years | |
| 5-year OS rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Province Clinical Site | Anhui Province | China | ||||
| Beijing Clinical Site1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38906161 | Derived | 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. | |
| 35623069 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tegafur-gimeracil-oteracil potassium | Drug | Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off |
|
| Oxaliplatin | Drug | Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. |
|
| Capecitabine | Drug | Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off. |
|
| Placebo | Drug | Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year). |
|
| 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 |
| 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 |
| Derived |
| Chang 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. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided