NCT03170310Unknown2 期
Apatinib Treatment for Advanced Esophagus Cancer ,One-armed，Exploratory，Openting , Clinical Trail.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progress free survival
研究概览
简要总结
Subject ever received a standard chemotherapy solution progression or recurrence or can't tolerate chemotherapy with advanced esophageal squamous carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 75 years old, men and women;
- •After histopathological and immunohistochemical examination diagnosis of esophageal squamous cell carcinomas. At least one measurable lesion after the treatment (the length to diameter of CT scan≥10 mm , accord with the requirement of RESCIST 1.1);the lesions of whom had not received radiotherapy.
- •Advanced esophageal squamous cell carcinoma without molecular targeted drug therapy;
- •ECOG PS:0-1;
- •Life expectancy≥12 weeks;
- •Patients who have disease progressed or relapsed after standard chemotherapy, or who have been unable to tolerate chemotherapy;
- •The main organs function properly, that is, meet the following criteria:
- •blood routine examination: HB≥90 g / L; (without blood transfusion during 14 days) ANC≥1.5×109 /L; PLT≥80×109 / L;
- •biochemical examination: ALB≥30g / L; (without infusion of albumin during 14 days) ALT and AST<2ULN; TBIL≤1.5ULN; Plasma Cr≤1.5ULN;
- •The results of the serum pregnancy test of women in childbearing age must be negative in the 7 days prior to treatment; all patients (both male and female) should take adequate barrier contraception within the entire treatment and 4 weeks after treatment.
- •Subject should volunteer to join the study, sign the informed consent, have good compliance and cooperate with the follow-up;
- •Investigator believe that subject who can benefit.
排除标准
- •In the past or at the same time with suffered from other malignancies;
- •Pregnant or lactating women;
- •Patients with high blood pressure and can't get a good control after antihypertensive drug therapy (systolic blood pressure>150mmHg, diastolic blood pressure>100mmHg); patients with grade Ⅱ or more myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTC interval≥450ms) and Ⅲ~Ⅳ grade cardiac insufficiency according to NYHA; cardiac color Doppler ultrasonography: LVEF <50%;
- •Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the drug taking and absorption;
- •With a clear risk of gastrointestinal bleeding (such as locally active ulcer lesions, fecal occult blood above + +), history of gastrointestinal bleeding within 6 months, and unhealed wounds;
- •Central nervous system metastasis has occurred;
- •With abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
- •With mental illness, or mental history of drug abuse;
- •With anastomotic recurrence;
- •Patients who have participated in other drug clinical trials in 4 weeks;
- •Patients who have concomitant diseases that are seriously compromise the patient's safety or affect the patient to complete the study according to the researcher's judgment;
- •Patients those researchers believe not suitable for the inclusion.
研究组 & 干预措施
Apatinib
Experimental
干预措施: Apatinib (Drug)
结局指标
主要结局
Progress free survival
时间窗: 24 months
Time subject into the group to tumor objective progression.
次要结局
- Overall survival(up to 24 months)
研究者
研究点 (1)
Loading locations...
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