A Randomized, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Sintilimab Combined With Ramucirumab as Compared to Chemotherapy for the First-line Treatment of Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (ORIENT-106)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and tolerability of sintilimab plus ramucirumab,Overall survival (OS)
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of sintilimab plus ramucirumab compared to stand of care first-line chemotherapy in participants with advanced gastric or esophagogastric adenocarcinoma.
详细描述
This is a randomized, multicenter, phase 3 study to evaluate the efficacy and safety of sintilimab combined with ramucirumab as compared to stand of care chemotherapy for the first-line treatment of PD-L1 positive, unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
The primary endpoint of this study is OS of the ITT population.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sintilimab + Ramucirumab
Ramucirumab on days 1 and 8 in combination with Sintilimab on day 1 of each 21-day cycle until disease progression, intolerable toxicity or other criteria for treatment discontinuation
干预措施: Sintilimab (Drug)
Sintilimab + Ramucirumab
Ramucirumab on days 1 and 8 in combination with Sintilimab on day 1 of each 21-day cycle until disease progression, intolerable toxicity or other criteria for treatment discontinuation
干预措施: Ramucirumab (Drug)
Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine
Cisplatin on day 1 in combination with 5-fluorouracil, continuous pumping for 24 hours a day on days 1 to 5 of each 21-day cycle. (FP regimen) or Oxaliplatin on day 1 in combination with capecitabine on days 1 to 14 of each 21-day cycle. (XELOX regimen)
干预措施: Cisplatin (Drug)
Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine
Cisplatin on day 1 in combination with 5-fluorouracil, continuous pumping for 24 hours a day on days 1 to 5 of each 21-day cycle. (FP regimen) or Oxaliplatin on day 1 in combination with capecitabine on days 1 to 14 of each 21-day cycle. (XELOX regimen)
干预措施: 5-fluorouracil (Drug)
Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine
Cisplatin on day 1 in combination with 5-fluorouracil, continuous pumping for 24 hours a day on days 1 to 5 of each 21-day cycle. (FP regimen) or Oxaliplatin on day 1 in combination with capecitabine on days 1 to 14 of each 21-day cycle. (XELOX regimen)
干预措施: Oxaliplatin (Drug)
Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine
Cisplatin on day 1 in combination with 5-fluorouracil, continuous pumping for 24 hours a day on days 1 to 5 of each 21-day cycle. (FP regimen) or Oxaliplatin on day 1 in combination with capecitabine on days 1 to 14 of each 21-day cycle. (XELOX regimen)
干预措施: Capecitabine (Drug)
结局指标
主要结局
Safety and tolerability of sintilimab plus ramucirumab,Overall survival (OS)
时间窗: Randomization to Death from Any Cause, up to 60 months
OS is time from the date of randomization to the date of death from any cause. If the participant is alive at the cutoff for analysis (or was lost to follow-up), OS data is censored for analysis on the last date the participant is known to be alive.
次要结局
- Progression-free Survival (PFS)(Randomization to Radiological Disease Progression or Death from Any Cause (Up to 24 Months))
- Objective Response Rate [ORR] (Percentage of Participants With Complete Response [CR] or Partial Response [PR])(Randomization to Disease Progression (Up To 24 Months))
- Duration of Response (DoR)(Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 24 Months))
- Number of participants experiencing an adverse event (AE)(Randomization to end of study (up to 24 months))
- Disease Control Rate [DCR] (Percentage of Participants With Complete Response [CR], Partial Response [PR] or Stable Disease [SD])(Randomization to Disease Progression (Up To 24 Months))