NCT03213587Unknown2 期
Apatinib in Treating Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Had Failed Prior Platinum Based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- CBR(Clinical Benefit Rate)
研究概览
简要总结
To evaluate the efficacy and safety of apatinib in treating patients with recurrent or metastatic nasopharyngeal carcinoma who failed prior platinum based chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologic confirmed recurrent and/or metastatic nasopharyngeal carcinoma( NPC )
- •Have failed for ≥1 lines of platinum based chemotherapy
- •At least one measurable lesion according to the RECIST 1.1
- •≥ 18 and ≤ 65 years of age
- •ECOG performance scale 0-2
- •Life expectancy of more than 3 months
- •Adequate hepatic, renal and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 100×10^9/L, neutrophils ≥ 1.5×10^9/L, serum transaminase < 2.5×the upper limit of normal(ULN), (If liver metastases, serum transaminase< 5×the ULN), creatinine clearance rate > 60ml/min.
- •Signed and dated informed consent.
排除标准
- •Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR and PDGFR
- •Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Any factors that influence the usage of oral administration
- •Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening
- •Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
- •Within 3 months before the first treatment occurs myocardial infarction, unstable angina pectoris, cardiac angioplasty or stent implantation
- •Within 1 months before the first treatment received surgical operation and the wounds were not healed
- •Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed
- •Blood coagulation abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation.
- •Preexisting serious accompanying disease which may bring great risk or influence the patient's compliance( uncontrolled hypertension, grade III - IV cardiac insufficiency, severe arrhythmia -QTc duration between 500 m/s, severe liver and kidney insufficiency :urine protein+ +, 24 hours urinary protein > 1.0 g, mental illness.)
- •history of organ transplants
- •Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
研究组 & 干预措施
apatinib
Experimental
干预措施: Apatinib (Drug)
结局指标
主要结局
CBR(Clinical Benefit Rate)
时间窗: 12 weeks
The sum rate of complete response, partial response and stable disease
The incidence of Grade 3-4 adverse events
时间窗: 2 years
Number of participants with adverse events and serious adverse events.In addition,estimating their relationship with apatinib.
次要结局
- OS (overall survival)(2 years)
- QoL(quality of life)(2 years)
- PFS (progression free survival)(2 years)
研究者
Chen Xiaozhong
Director,Department of radiation oncology, Principal Investigator, Clinical Professor
Zhejiang Cancer Hospital
研究点 (1)
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