NCT03542422Unknown2 期
An Exploratory and Open Clinical Study of Apatinib Mesylate as First-line Treatment for Advanced Esophagus Cancer.
Affiliated Hospital of North Sichuan Medical College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progress free survival（PFS）
研究概览
简要总结
An Exploratory study of Amapinib for patients with advanced esophagus cancer .
详细描述
An Exploratory study of Amapinib for patients with advanced esophagus cancer .
Eligible are patients with advanced esophagus cancer. Apatinib (500mg) is given daily as follows:
Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy One therapy cycle has 28 days. Tumor response is evaluated every 2 cycles.
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;
- •Patients diagnosed with esophageal squamous cell carcinoma by histopathology and immunohistochemistry;
- •ECOG performance status: 0-2;
- •Life expectancy ≥ 12 weeks;
- •Clinical stage IIIb-IV; metastatic patients who have not initially received chemotherapy or patients who have local recurrence after surgery or radiochemotherapy (no local treatment indication) ;
- •Function of the major organs is normal, criteria referred are as follow:
- •blood routine examination: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L;
- •biochemical examination: ALB ≥ 29 g / L (AlB did not lose within 14 days); ALT and AST <5 ULN; TBIL ≤ 1.5 ULN;
- •plasma examination Cr ≤ 1.5 ULN;
- •Subjects voluntarily participated in the study, signed informed consent, have good compliance and cooperate with follow-up;
- •Patients that the investigator believes can benefit.
排除标准
- •Those who have had other malignant tumors in the past or at the same time;
- •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, which significantly affects drug taking and absorption;
- •Have a clear risk of gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + or more), a history of gastrointestinal bleeding within 6 months;
- •6.With coagulation abnormalities (PT>16 s, APTT>43 s, TT>21 s, Fbg <2 g/L), hemorrhagic tendency or receiving thrombolysis or anticoagulant therapy;
- •Have a mental illness, or history of abuse of psychotropic substances;
- •With anastomotic recurrence and tracheal fistula;
- •Patients who participated in other drug clinical trials within 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;
- •Researchers believe that it is not suitable for inclusion.
研究组 & 干预措施
Apatinib
Experimental
Apatinib 500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity.
干预措施: Apatinib (Drug)
结局指标
主要结局
Progress free survival（PFS）
时间窗: 12months
Time subject into the group to tumor objective progression.
次要结局
- Overall Survival(up to12months)
研究者
研究点 (1)
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