A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 92
- 主要终点
- Relapse-free survival (RFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Nivolumab (Drug)
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.
干预措施: Tegafur-gimeracil-oteracil potassium (Drug)
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.
干预措施: Oxaliplatin (Drug)
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.
干预措施: Capecitabine (Drug)
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.
干预措施: Tegafur-gimeracil-oteracil potassium (Drug)
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.
干预措施: Oxaliplatin (Drug)
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.
干预措施: Capecitabine (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Relapse-free survival (RFS)
时间窗: 5 years
次要结局
- 3-year RFS rate(3 years)
- Overall survival (OS)(5 years)
- 3-year OS rate(3 years)
- 5-year OS rate(5 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)