NCT03649945Unknown2 期
An Open-label, Randomized Clinical Trial of Recombinant Human Endostatin (Endo) Combined With Chemotherapy Compared With Chemotherapy for Adjuvant Treatment of Esophageal Cancer
First Affiliated Hospital of Guangxi Medical University0 个研究点目标入组 186 人开始时间: 2018年11月最近更新:
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
- 186
- 主要终点
- 3 year disease-free survival rate
研究概览
简要总结
This is an open-label, randomized trial, it compares the efficacy and safety between apatinib combined chemotheray and chemotherapy for adjuvant treatment of esophageal cancer
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
- •IIA-IIIC phase esophageal squamous cell carcinoma confirmed by histopathology and immunohistochemistry.
- •R0 resection has been performed at least before 4 weeks.
- •ECOG PS score: 0-1 points.
- •Estimated survival time: at least 12 weeks.
- •No radiotherapy, chemotherapy or molecular targeted therapy before.
- •Main organs are functional, which meet the following criteria:
- •Blood Routine:
- •HB≥90 g/L（No blood transfusion within 14 days）, ANC≥1.5×109/L, PLT ≥80×109/L. Biochemical examination： ALB≥30g / L（No blood transfusion within 14 days）, ALT<2ULN； AST<2ULN TBIL≤1.5ULN； Plasma Cr≤1.5ULN；
- •Volunteer with signed informed consent form, good compliance and good follow-up cooperation.
- •Patients who the investigator believws they 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 grade-II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTC interval ≥ 450 ms) and cardiac dysfunction according to NYHA criteria III to IV. Cardiac color Doppler examination: LVEF (left ventricular ejection) Score) <50%.
- •Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++), and a history of gastrointestinal bleeding within 6 months.
- •Have a history of mental illness or psychotropic substance abuse.
- •Patients who have participated in other drug clinical trials within 4 weeks.
- •According to the investigator's judgment, patients who are at a risk or have accompanying disease.
- •Patients who believe that they are unsuitable for inclusion.
研究组 & 干预措施
Test Group 1
Active Comparator
Docetaxel plus Nedaplatin combined with Endostar
干预措施: Docetaxel (Drug)
Test Group 1
Active Comparator
Docetaxel plus Nedaplatin combined with Endostar
干预措施: Nedaplatin (Drug)
Test Group 1
Active Comparator
Docetaxel plus Nedaplatin combined with Endostar
干预措施: Endostar (Drug)
Test Group 2
Active Comparator
Docetaxel plus Nedaplatin
干预措施: Docetaxel (Drug)
Test Group 2
Active Comparator
Docetaxel plus Nedaplatin
干预措施: Nedaplatin (Drug)
结局指标
主要结局
3 year disease-free survival rate
时间窗: 3 years
the percentage of the patients whose disease cannot be detected after curative therapy in three years
次要结局
- overall survival(3 years)
研究者
Jie Ma
Director
First Affiliated Hospital of Guangxi Medical University
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