Study of Adjuvant ONO-4538 With Resected Gastric Cancer

Phase 3

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Nivolumab; Drug: Tegafur-gimeracil-oteracil potassium; Drug: Oxaliplatin; Drug: Placebo; Drug: Capecitabine

• 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

Study Timeline

• Study First Submitted: 2016-12-27
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-30
• Study Start: 2017-01-31
• Primary Completion: 2022-08-17
• Study Completion: 2023-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

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
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
5-year RFS rate	5 years
3-year RFS rate	3 years

Trial Locations

Locations (92)

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

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