Maintenance Treatment With Capecitabine Plus Apatinib vs. Apatinib and Observation After First-line XELOX/SOX Chemotherapy for Patients With Advanced Gastric Cancer: a Multicenter, Randomized, Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This is a multicenter, randomized, controlled trial to evaluate the efficacy and safety of Maintenance Treatment with Capecitabine plus Apatinib, Apatinib and Observation after First-line XELOX/SOX chemotherapy for Patients with 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-75；
- •had histologically confirmed unresectable and/or metastatic (primary or recurrent) adenocarcinoma of the stomach or gastroesophageal junction；
- •received 4-6 cycles of Xelox/SOX regimens as first-line chemotherapy and the response was not progression disease (PD);
- •Patients were tested for tumor HER2 status before treatment, and patients with HER2-negative disease；
- •presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines；
- •Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
- •Adequate organ function as defined below: Hematologic ANC ≥ 2*109/L, Platelets ≥ 100*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN
- •Receiving no form of chemotherapy, targeted therapy or other study medication;
排除标准
- •previous radiotherapy to the abdomen；
- •previous treatment for advanced disease (neoadjuvant chemotherapy was permitted if administered >6 months before enrollment)；
- •pregnant or lactating women or women of childbearing potential；
- •disease progression during the first-line chemotherapy;
- •active gastrointestinal bleeding, arterial thrombosis or cerebrovascular accident within 6 months before enrollment
- •previous treatment of apatinib and Ramucirumab
研究组 & 干预措施
Maintenance Treatment Group A
Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
干预措施: Apatinib+Capecitabine (Drug)
Maintenance Treatment Group B
Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
干预措施: Apatinib (Drug)
结局指标
主要结局
PFS
时间窗: 36 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
次要结局
- OS(36 months)
研究者
Xianglin Yuan
Professor, Chief physician
Huazhong University of Science and Technology