A Phase I/II Clinical Study to Compare Postoperative Chemotherapy of Oxaliplatin With Capecitabine（XELOX）Combined With APATINIB as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
To observe and evaluate the efficacy and safety of oxaliplatin with oapecitabine（XELOX）combined with apatinib as post-operative chemotherapy in locally advanced gastric adenocarcinoma with D2 dissection
详细描述
Stage 1 (phase I tolerance study) : 12 patients were enrolled in the dose-climbing study:According to the principle of dose-climbing test,todetermine the subjects' MTD, with the following three dose levels:
- Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 250 mg, qd x180d; ②. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 375 mg, qd x180d; ③. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 500 mg, qd x180d;
Stage 2 (phase II exploratory study) :
①.Test group: subjects received 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib maximum tolerated dose
②.Control group: Subjects received 8 cycles of XELOX regimen after surgery (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG score is 0-1;
- •Radical gastrectomy (D2, R0) for gastric cancer has been performed (more than 16 lymph nodes have been detected);
- •Postoperative histology confirmed gastric adenocarcinoma；
- •The pathological stage of gastric cancer is ⅢA-ⅢC stage (8th AJCC TNM);
- •Subjects' baseline blood routine and biochemical indicators meet the following standards:
- •ANC≥1.5×109/L;
- •Hb≥90g/L;
- •PLT≥100×109/L;
- •TBIL≤1.5×ULN;
- •ALT and AST≤2×ULN;
- •Cr≤1.5×ULN
- •INR：1.0～1.5; APTT is within the normal range
- •The electrocardiogram was basically normal before the first 4 weeks after admission, and there were no obvious clinical symptoms of heart disease;
- •Sign informed consent.
排除标准
- •Patients with severe hypertension and poor drug control;
- •Various factors that affect oral drugs such as (inability to swallow, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation ) ;
- •Patients with previous bradycardia or prolonged QT interval;
- •Patients with postoperative gastrointestinal fistula and wound rupture;
- •Known allergy to capecitabine or oxaliplatin, or metabolic disorder;
- •Patients receiving preoperative chemotherapy, radiotherapy or targeted therapy before;
- •Patients Using other experimental drugs at the same time or joining in other clinical trials.
- •Patients with severe liver diseases (such as liver cirrhosis), nephropathy, respiratory diseases or chronic systemic diseases such as uncontrollable diabetes and hypertension; Clinical symptoms of heart disease,such as congestive heart failure,coronary heart disease symptoms, arrhythmia, hypertension,that hard to control,or having myocardial infarction attack in six months or cardiac insufficiency.
- •Patients with peripheral nervous system disorder or with a history of significant psychiatric disorder and central nervous system disorder;
研究组 & 干预措施
treatment group
8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib'MTD(maximum tolerated dose)
干预措施: Apatinib (Drug)
Control group
8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w)
干预措施: Apatinib (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 3 months
Disease-free survival (DFS) is defined as the time from the beginning of treatment to Disease recurrence or death due to Disease progression
次要结局
未报告次要终点