A Randomized, Multicenter Study To Evaluate The Efficacy And Safety Of Apatinib Versus Docetaxel In Patients With Previously Treated Locally Advanced Or Metastatic Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This multicenter, randomized study will evaluate the efficacy and safety of apatinib compared to docetaxel treatment in patients with advanced gastric cancer. At the start of the trial, patients will be randomized to one treatment arm: Arm A: apatinib 850mg qd every 3 weeks; Arm B: docetaxel 60mg/m2 every 3 weeks. Tumor assessment will be done every 8 weeks according to RECIST 1.1. The primary endpoint is progression free survival (PFS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, aged ≥18 years;
- •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);
- •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 × 109/L, neutrophil ≥1.5 × 109/L, serum creatinine≤ 1.5mg/dl, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);
排除标准
- •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); Uncontrolled hypertension;
- •Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;
- •Urine protein>grade 1;
- •Any factors that influence the usage of oral administration;
- •patients with a clear tendency of gastrointestinal bleeding;
- •Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN);
- •Abuse of alcohol or drugs;
- •Less than 4 weeks from the last clinical trial;
- •Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy;
- •Evidence of central nervous system(CNS) metastasis;
- •Disability of serious uncontrolled intercurrence infection.
研究组 & 干预措施
apatinib
Apatinib 850 mg qd po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: apatinib (Drug)
Docetaxel
Docetaxel 60mg/m2 ivgtt every 3 weeks, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Approximately 1 year
defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 8 weeks of therapy
次要结局
- Overall survival (OS)(Approximately 3 years)
- Objective response rate (ORR)(Approximately 1 year)
- Disease control rate(DCR)(Approximately 1 year)
- Safety (incidence of adverse events)(Approximately 1 year)
- Quality of life(QoL)(Approximately 3 years)
研究者
Tianshu Liu
Medicine-Oncology Derpartment of Zhongshan hospital
Shanghai Zhongshan Hospital