A Randomized, Double Blinded, Placebo Controlled Multicenter Phase III Study of Apatinib Mesylate Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 2
- 主要终点
- Progression Free Survival(PFS)
研究概览
简要总结
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histological confirmed advanced or metastatic adenocarcinoma of the stomach
- •Have failed for at least 2 lines of chemotherapy
- •Life expectancy of at least 12 weeks.
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before randomization.
- •At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
- •Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
- •More than 4 weeks for operation or radiotherapy
- •More than 4 weeks for cytotoxic agents or growth inhibitors
- •Adequate hepatic, renal, heart, and hematologic functions (HB ≥ 90g/L,platelets > 80 ×10 E+9/L, neutrophil > 1.5 × 10 E+9/L, serum creatinine ≤ 1× upper limit of normal(ULN), bilirubin < 1.25× 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 in-situ of uterine cervix Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
- •Any factors that influence the usage of oral administration; Evidence of Central Nerves System(CNS) metastasis
- •Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria ≥ (+)
- •International Normalize Ratio (INR) > 1.5 and activated partial thromboplastin time（APPT） > 1.5 × ULN
- •Abuse of alcohol or drugs
- •Certain possibility of gastric or intestine hemorrhage
- •Less than 4 weeks from the last clinical trial
- •Prior VEGFR inhibitor treatment
- •Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.
研究组 & 干预措施
apatinib
干预措施: apatinib (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Progression Free Survival(PFS)
时间窗: 30 months
Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Overall Survival(OS)
时间窗: 30 months
Overall Survival of the Participants
次要结局
- Disease Control Rate(DCR)(30 months)
- Objective Response Rate(ORR)(30 months)
- Percentage of Participants With Adverse Events(30 months)