NCT03029013Unknown不适用
A Phase II Clinical Trial Study on Apatinib and Chemotherapy Sequential Treatment With Advanced Metastatic Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The study is the single arm and single center clinical trials，We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib and chemotherapy sequential treatment with advanced recurrence of metastatic cervical cancer
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The pathological diagnosis of recurrent or metastatic cervical cancer;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1;
- •Life expectancy of more than 3months;
- •With normal marrow, liver and renal function：
- •blood routine examination ：HB≥90g/L，ANC ≥1.5×10*9/L，PLT≥80×10*9/L；
- •Biochemical examination: total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL)，alanine aminotransferase (ALT) and aspartate aminotransferase (AST) of ≤2.5 UNL or ≤5 UNL ，acreatinine (Cr) of ≤ 1.25 UNL; creatinine clearance rate ≥ 45ml/min (Cockcroft-Gault);
- •With written informed consent signed voluntarily by patients themselves .
- •With good compliance and agree to accept follow-up of disease progression and adverse events.
排除标准
- •Uncontrolled hypertension
- •Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias
- •With abnormal coagulation function， bleeding tendency or treating with thrombolysis and anticoagulation
- •History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood ≥ (++), and vasculitis) =< 3 months prior to randomization;
- •uncured the wound or fracture
- •Centrally located tumors of local invasion of major blood vessels, or Researchers think that patients may invade the important blood vessels and cause fatal bleeding (CT or MRI);
- •Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction);
- •Urine protein >++, or urine protein in 24 hours> 1.0g
- •Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment
- •History of uncontrolled psychotropic drug abuse or mental disorders;
- •Prior VEGFR inhibitor treatment ;
- •Other malignancy within Before or at the same time other than basal cell skin cancer, or carcinoma in situ of the cervix;
研究组 & 干预措施
experimental group
Experimental
Apatinib and chemotherapy
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression free survival
时间窗: 24 months
次要结局
- overall survival(24 months)
研究者
Ge Wang
M.D.
Third Military Medical University
研究点 (1)
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