NCT04208347进行中（未招募）2 期
Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Multicenter, Randomized Phase II-III Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 580
- 试验地点
- 23
- 主要终点
- Event-free Survival (EFS)
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
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
- Single (Outcomes Assessor)
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
- •Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
- •Plans to proceed to surgery following pre-operative chemotherapy.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Has adequate organ function.
- •Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
- •Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
- •Has life expectancy of greater than 12 months.
排除标准
- •Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
- •Known hypersensitivity to any of the study drugs or excipients.
- •Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
- •Congenital or acquired immune deficiency (e.g. HIV infected)
研究组 & 干预措施
Apatinib and Camrelizumab and S-1 and Oxaliplatin
Experimental
干预措施: Apatinib 250mg (Drug)
Apatinib and Camrelizumab and S-1 and Oxaliplatin
Experimental
干预措施: Camrelizumab (Drug)
Apatinib and Camrelizumab and S-1 and Oxaliplatin
Experimental
干预措施: S-1, Oxaliplatin (Drug)
Apatinib and S-1 and Oxaliplatin
Experimental
干预措施: S-1, Oxaliplatin (Drug)
Apatinib and S-1 and Oxaliplatin
Experimental
干预措施: Apatinib 500mg (Drug)
S-1 and Oxaliplatin
Active Comparator
干预措施: S-1, Oxaliplatin (Drug)
结局指标
主要结局
Event-free Survival (EFS)
时间窗: Up to approximately 2 years
Pathological Complete Response (pCR)
时间窗: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
次要结局
- Major pathological response(MPR)(Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment)
- OS(up to 3 years)
- DFS(up to 2 years)
- AEs(Up to approximately 18 months)
- Margin-free (R0) resection rate(Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment)
- Downstaging of N stage(Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment)
研究者
研究点 (23)
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