Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer.
A Phase II Multicenter, Randomized, Double-blind Study of Apatinib Combined With Paclitaxol Versus Placebo With Paclitaxol as Second Line Therapy for Advanced Gastric / Esophagogastric Junction Adenocarcinoma With Peritoneal Metastasis.
This multicenter, randomized, double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis.
Patients will be randomized to one treatment arm: Arm A: apatinib 500mg qd, Paclitaxol 80mg/m2, d1, d8, d15,every 4 weeks ; Arm B: placebo 500mg qd, Paclitaxol 80mg/m2, d1, d8, d15,every 4 weeks ; Tumor assessment will be done every 8 weeks according to RECIST 1.1. The primary endpoint is progression free survival (PFS).
研究概览
详细说明
Gastric cancer is the second most common cause of cancer-related deaths worldwide, and most patients are diagnozed at advanced stage in China. Peritoneal metastasis is the most common metastatic site. For gastric cancer patients with peritoneal metastasis, chemotherapy can bring survival benefit versus best sportive care. Paclitaxol is the standard second line chemotherapy for advanced gastric cancer patients.
Apatinib mesylate is a small-molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor (TKI). It has been approved as third-line treatment for patients with advanced gastric adenocarcinoma in China.
This multicenter, randomized, double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Guangdong
-
Foshan、Guangdong、中国
- 招聘中
- Foshan people's Hospital
-
接触:
- Wei Wang
- 电话号码:075783161035
- 邮箱:m18038863618@163.com
-
Guangzhou、Guangdong、中国、510060
- 招聘中
- Cancer center of Sun Yat-sen University
-
接触:
- Miao-Zhen Qiu, MD, PhD
- 电话号码:86-020-87342490
- 邮箱:qiumzh@sysucc.org.cn
-
接触:
- Fenghua Wang, MD, PhD
- 电话号码:86-020-87342490
- 邮箱:wangfh@sysucc.org.cn
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult patients, aged between 18 and 75 years old;
- Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ;
- At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1); and confirmed as peritoneal metastasis by CT scan or laparoscope
- Patients must have received one prior chemotherapy regimen for AGC;First-line therapy must have included a combination of at least a platinum-based treatment given concurrently, and must have experienced disease progression during or after first-line therapy for their disease;
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
- Life expectancy of more than 3 months;
- Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy;
- Adequate hepatic, renal, heart, and hematologic functions ( hemoglobin≥ 90g/L, platelets ≥ 80 × 10*9/L, neutrophil ≥1.5 × 10*9/L, serum creatinine≤ 1.5mg/dl, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN)
Exclusion Criteria:
- Pregnant or lactating women;
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
- Prior chemotherapy regimen have included taxane (docetaxel or paclitaxel); 4. Uncontrolled hypertension;
5. Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure; 6. Urine protein>grade 1; 7. Any factors that influence the usage of oral administration; 8. Patients with a clear tendency of gastrointestinal bleeding; 9. Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN); 10. Abuse of alcohol or drugs; 11. Less than 4 weeks from the last clinical trial; 12. Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy; 13. Evidence of central nervous system(CNS) metastasis; 14. Disability of serious uncontrolled intercurrence infection.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Experimental group
Apatinib: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
|
Apatinib 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
其他名称:
|
安慰剂比较:Placebo group
Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
|
Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Progression-free survival (PFS)
大体时间:Approximately 1 year
|
The time from randomize to progression or death
|
Approximately 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Overall survival (OS)
大体时间:Approximately 3 years
|
The time from randomize to death
|
Approximately 3 years
|
Objective response rate (ORR)
大体时间:Approximately 1 year
|
The rate of complete response and partial response according to RECIST guidelines
|
Approximately 1 year
|
Disease control rate(DCR)
大体时间:Approximately 1 year
|
The rate of complete response , partial response and stable disease according to RECIST guidelines
|
Approximately 1 year
|
Safety (incidence of adverse events) [
大体时间:Approximately 1 year
|
Incidence of adverse events
|
Approximately 1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Apatinib的临床试验
-
Sun Yat-sen UniversityJiangsu Hengrui Pharmaceutical Co., Ltd.尚未招聘