A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 242
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.
详细描述
Up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. Our study is designed to prove whether the maintenance treatment of Apatinib or Capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in advanced gastric cancer
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
- •ECOG PS 0-2
- •At least one measurable or evaluable lesion in the first-line chemotherapy
- •The fist line treatment should be 5-FU based regimen (e.g. ECF/EOF/EOX/FOLFOX/XELOX/XP) , and patients should received 6 cycles (3-week regimen) or 12 cycles (2-week regimen) treatment with the efficacy of non-PD
- •The time from the last cycle treatment to the enrollment cannot exceed 6 weeks
- •Adequate hepatic, renal, heart, and hematologic functions (platelets ≥75×109/L, neutrophil ≥1.5×109/L, hemoglobin ≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase ≤2.5× the ULN)
排除标准
- •Received 2 or more regimens for palliative chemotherapy
- •Pregnant or lactating women
- •Concurrent cancer, or history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Uncontrolled brain, or leptomeningeal involvement, complete intestinal obstruction
- •Clinically significant active bleeding, OB 2+ or higher
- •Patients with locally advanced gastric cancer who are scheduled to receive radiotherapy
- •Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
- •Uncontrolled significant comorbid conditions
研究组 & 干预措施
Apatinib
In this arm, patients will receive a daily oral treatment with Apatinib 500mg.
干预措施: Apatinib (Drug)
Capecitabine
In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: six weeks
PFS is calculated from the time of randmization to disease progression or death whichever happen first
次要结局
- Overall Survival (OS)(six weeks)
研究者
Xiaodong Zhu
Principal Investigator and Clinical Professor
Fudan University