Study of Adjuvant ONO-4538 With Resected Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006705
• Other study ID #: ONO-4538-38
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 2017
• Est. completion date: March 31, 2023

Study information

• Verified date: December 2023
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: March 31, 2023
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Nivolumab
Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
• Tegafur-gimeracil-oteracil potassium
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
• Oxaliplatin
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
• Capecitabine
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
• Placebo
Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).

Locations

Country	Name	City	State
China	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
Japan	Hyogo Clinical Site	Akashi	Hyogo
Japan	Hyogo Clinical Site	Amagasaki	Hyogo
Japan	Tokyo Clinical Site	Bunkyo-ku	Tokyo
Japan	Chiba Clinical Site	Chiba
Japan	Tokyo Clinical Site	Chuo-ku	Tokyo
Japan	Fukuoka Clinical Site 1	Fukuoka
Japan	Fukuoka Clinical Site 2	Fukuoka
Japan	Hiroshima Clinical Site	Fukuyama	Hiroshima
Japan	Gifu Clinical Site	Gifu
Japan	Hokkaido Clinical Site 3	Hakodate	Hokkaido
Japan	Saitama Clinical Site	Hidaka	Saitama
Japan	Osaka Clinical Site	Hirakata	Osaka
Japan	Hiroshima Clinical Site1	Hiroshima
Japan	Hiroshima Clinical Site2	Hiroshima
Japan	Hiroshima Clinical Site3	Hiroshima
Japan	Chiba Clinical Site	Kamogawa	Chiba
Japan	Ishikawa Clinical Site	Kanazawa	Ishikawa
Japan	Saitama Clinical Site	Kitaadachi-gun	Saitama
Japan	Kochi Clinical Site	Kochi
Japan	Tokyo Clinical Site	Koto-ku	Tokyo
Japan	Kumamoto Clinical Site	Kumamoto
Japan	Okayama Clinical Site	Kurashiki	Okayama
Japan	Kyoto Clinical Site	Kyoto
Japan	Ehime Clinical Site	Matsuyama	Ehime
Japan	Ehime Clinicla Site	Matsuyama	Ehime
Japan	Iwate Clinical Site	Morioka	Iwate
Japan	Aichi Clinical Site1	Nagoya	Aichi
Japan	Aichi Clinical Site2	Nagoya	Aichi
Japan	Niigata Clinical Site	Niigata
Japan	Hyogo Clinical Site	Nishinomiya	Hyogo
Japan	Gifu Clinical Site	Ogaki	Gifu
Japan	Osaka Clinical Site1	Osaka
Japan	Osaka Clinical Site2	Osaka
Japan	Osaka Clinical Site3	Osaka
Japan	Osaka Clinical Site4	Osaka
Japan	Osaka Clinical Site	Osaka-sayama	Osaka
Japan	Miyagi Clinical Site	Osaki	Miyagi
Japan	Gunma Clinical Site	Ota	Gunma
Japan	Kanagawa Clinical Site	Sagamihara	Kanagawa
Japan	Osaka Clinical Site	Sakai	Osaka
Japan	Nagano Clinical Site	Saku	Nagano
Japan	Hokkaido Clinical Site 1	Sapporo	Hokkaido
Japan	Hokkaido Clinical Site2	Sapporo	Hokkaido
Japan	Tochigi Clinical Site	Shimotsuke	Tochigi
Japan	Tokyo Clinical Site	Shinjuku-ku	Tokyo
Japan	Shizuoka Clinical Site	Shizuoka
Japan	Osaka Clinical Site	Suita	Osaka
Japan	Shizuoka Clinical Site	Sunto-gun	Shizuoka
Japan	Gunma Clinical Site	Takasaki	Gunma
Japan	Osaka Clinical Site	Takatsuki	Osaka
Japan	Toyama Clinical Site	Toyama
Japan	Osaka Clinical Site	Toyonaka	Osaka
Japan	Wakayama Clinical Site	Wakayama
Japan	Yamagata Clinical Site	Yamagata
Japan	Kanagawa Clinical Site	Yokohama	Kanagawa
Korea, Republic of	Busan Clinical Site1	Busan
Korea, Republic of	Busan Clinical Site2	Busan
Korea, Republic of	Busan Clinical Site3	Busan
Korea, Republic of	Daegu Clinical Site1	Daegu
Korea, Republic of	Daegu Clinical Site2	Daegu
Korea, Republic of	Daegu Clinical Site3	Daegu
Korea, Republic of	Daejeon Clinical Site 1	Daejeon
Korea, Republic of	Daejeon Clinical Site 2	Daejeon
Korea, Republic of	Gwangju Clinical Site	Gwangju
Korea, Republic of	Gyeonggi-do Clinical Site1	Gyeonggi-do
Korea, Republic of	Gyeonggi-do Clinical Site2	Gyeonggi-do
Korea, Republic of	Gyeonggi-do Clinical Site3	Gyeonggi-do
Korea, Republic of	Gyeonggi-do Clinical Site4	Gyeonggi-do
Korea, Republic of	Gyeonggi-do Clinical Site5	Gyeonggi-do
Korea, Republic of	Jeollabuk-do Clinical Site	Jeollabuk-do
Korea, Republic of	Seoul Clinical Site 8	Seoul
Korea, Republic of	Seoul Clinical Site 9	Seoul
Korea, Republic of	Seoul Clinical Site1	Seoul
Korea, Republic of	Seoul Clinical Site2	Seoul
Korea, Republic of	Seoul Clinical Site3	Seoul
Korea, Republic of	Seoul Clinical Site4	Seoul
Korea, Republic of	Seoul Clinical Site5	Seoul
Korea, Republic of	Seoul Clinical Site6	Seoul
Korea, Republic of	Seoul Clinical Site7	Seoul
Taiwan	Kaohsiung Clinical Site	Kaohsiung
Taiwan	Kaohsiung Clinical Site2	Kaohsiung
Taiwan	New Taipei Clinical Site	New Taipei
Taiwan	Taichung Clinical Site	Taichung
Taiwan	Tainan Clinical Site	Tainan
Taiwan	Tainan Clinical Site2	Tainan
Taiwan	Taipei Clinical Site1	Taipei
Taiwan	Taipei Clinical Site2	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd	Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival (RFS)		5 years
Secondary	Overall survival (OS)		5 years
Secondary	3-year OS rate		3 years
Secondary	5-year OS rate		5 years
Secondary	3-year RFS rate		3 years
Secondary	5-year RFS rate		5 years
Secondary	Safety will be analyzed through the incidence of adverse events, serious adverse events		Up to 28 days from last dose
Secondary	Safety will be analyzed through the incidence of laboratory abnormalities		Up to 28 days from last dose