NCT03355612尚未招募3 期
A Randomized, Multicenter, Controlled Study of XELOX (Oxaliplatin With Capecitabine) Combined With Apatinib Versus XELOX as Post-operative Chemotherapy in Locally Advanced Gastric Signet Ring Carcinoma With D2 Dissection.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 456
- 主要终点
- Disease Free Survival(DFS)
研究概览
简要总结
This is a randomized, multicenter, controlled study to compared the Efficacy and Safety of XELOX combined with Apatinib versus XELOX as post-operative chemotherapy in locally advanced gastric signet ring carcinoma with D2 dissection.
详细描述
The purpose of this study is to prove that as for disease free survival time, and safety, Apatinib with XELOX(Oxaliplatin with Capecitabine) has a better effect over that of XELOX adjunct therapy group for postoperative chemotherapy of locally advanced gastric signet ring carcinoma with D2 dissection.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 and ≤ 70 years of age;
- •Eastern Cooperative Oncology Group Performance Status: 0-1;
- •Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16);
- •Postoperative histological proven gastric signet-ring cell carcinoma(or contains signet-ring cell carcinoma);
- •Pathological stage:IIIA-IIIC（8th AJCC TNM）;
- •Patients have adequate baseline organ and marrow function :hemoglobin≥9g/dL; absolute neutrophil count (ANC) ≥1,500/mm3; PLT(platelets)≥1000,000/mm3; total bilirubin ≤1.5×upper normal limit(ULN); AST ≤2.5 ×ULN, ALT ≤2.5 ×ULN; prothrombin time-international normalized ratio≤1.5, and APTT(activated partial thromboplastin time) was within normal range; creatine ≤ 1.5 x ULN;
- •The ECG(electrocardiography) was basically normal in the 4 weeks before the study, and there was no obvious clinical symptoms of heart disease;
- •sign informed consent.
排除标准
- •Patients with hypertension and uncontrolled hypertension with hypotensive drugs therapy ;
- •Patients with dysphagia, complete or incomplete digestive tract obstruction, gastrointestinal bleeding, perforation, etc;
- •Patients had bradycardia or a QT extension;
- •Patients had gastrointestinal fistula and lacerations after surgery;
- •Allergic to capecitabine or oxaliplatin, or metabolic disorders;
- •Patients accepted Preoperative chemotherapy, radiotherapy or targeted therapy;
- •Attending other drug clinical trials;
- •Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms（such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency）;
- •Patients with peripheral nervous system disorder or apparent mental disorders or had the history of central nervous system disorders;
- •Patients with serious infection(above CTCAE grade 2);
- •Patient with history of another malignant cancer within past 5 years（not including: cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor );
- •Have the history of organ transplantation, Or have received systemic steroid therapy for a long time (note: short term user stopping medication >2 weeks can be included);
- •Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study;
- •Patients without legal capacity,or medical/ethical reasons may influence the study to continue.
研究组 & 干预措施
experimental group
Experimental
Drug:Apatinib with XELOX(Capecitabine and Oxaliplatin)
干预措施: Apatinib (Drug)
experimental group
Experimental
Drug:Apatinib with XELOX(Capecitabine and Oxaliplatin)
干预措施: XELOX (Drug)
active comparator
Active Comparator
Drug:XELOX(Capecitabine and Oxaliplatin)
干预措施: XELOX (Drug)
结局指标
主要结局
Disease Free Survival(DFS)
时间窗: 5 years
Disease Free Survivalof the Participants
次要结局
- Overall Survival(OS)(8 years)
- Percentage of Participants With Adverse Events(5 years)
研究者
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