NCT02683655Unknown2 期
Study of Apatinib in Metastatic Esophageal Cancer：A Open Label, Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal Cancer.
详细描述
Eligible patients will receive apatinib treatment until disease progression or intolerable toxicity or patients withdrawal of consent after the failure of chemotherapy or radiotherapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to75 years old;
- •Pathologically diagnosed with metastatic esophageal squamous cell cancer with measurable metastases outside the stomach (measuring ≥ 10mm on spiral CT scan, satisfying the criteria in RECIST 1.1);
- •Failed in first-line chemotherapy or radiotherapy treatment;
- •ECOG PS of 0-1;
- •An expected survival of ≥ 3 months;
- •No treated by molecularly targeted therapy. If have received chemotherapy, radiotherapy or surgery, must ≥4 weeks, and adverse reactions or wound has been completely restored;
- •Major organ function has to meet the following criteria:
- •ANC ≥ 1.5 × 109 / L; HB ≥ 90g / L; PLT ≥ 100 × 109 / L; ALB≥30g / L; TBIL≤1.5 times the upper limit of normal (ULN); ALT and AST<2 × ULN; Plasma Cr<1.5 × ULN
- •Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
- •Researchers believe that patients can benefit;
排除标准
- •Pts with other malignant tumor at the same time or in the past.
- •Pregnant or lactating women;
- •Subjects with poor-controlled arterial hypertension (systolic blood pressure>150 mmHg and diastolic blood pressure>100 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; Echocardiography: LVEF (LVEF)<50%;
- •Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- •Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 6 months;
- •Associated with CNS (central nervous system) metastases;
- •Abnormal Coagulation, with tendency of bleed;
- •With psychotropic drug abuse history and can't get rid of or mental disorder patients;
- •Anastomotic recurrence;
- •Participated in other clinical trials within 4 weeks;
- •Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
- •Other conditions regimented at investigators' discretion.
研究组 & 干预措施
Apatinib 500mg qd p.o.
Experimental
Apatinib Mesylate Tablets 500 mg qd p.o. after the failure of chemotherapy or radiotherapy
干预措施: Apatinib (Drug)
Apatinib 750mg qd p.o.
Experimental
Apatinib Mesylate Tablets 750 mg qd p.o. after the failure of chemotherapy or radiotherapy
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression free survival
时间窗: An expected average of 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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