NCT03857763Unknown2 期
A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma
Hebei Medical University Fourth Hospital0 个研究点目标入组 40 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 主要终点
- The pathological complete response rate(pCR)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of apatinib plus concurrent neoadjuvant chemoradiotherapy in patients with esophageal squamous cell 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18 to 70 years old (man or female);
- •Pathologically diagnosed with esophageal squamous cell carcinoma;
- •Patients with Stage for Ⅱ-Ⅲ(T2-4N0/+M0) (According to transesophageal ultrasonography;
- •Patients with measurable lesions(According to the criteria in RECIST1.1);
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Life expectancy greater than or equal to 3 months;
- •Major organ function has to meet the following certeria:
- •(1) For results of blood routine test
- •ANC≥1.5×109/L;
- •PLT≥90×109/L; (2) For results of blood biochemical test
- •a) ALT and AST≤2.5×ULN; b) TBIL<1.5×ULN; c) Serum creatinine ≤1.5×ULN;
- •Doctors believe that treatment can bring benefits to patients;
- •Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
排除标准
- •Have received prior treatment with chemotherapy or radiotherapy；
- •Have high blood pressure and antihypertensive drug treatment can not control;
- •Patients with severe cardiovascular disease ;
- •Accompanied by esophageal perforation and esophagotracheal fistula;
- •Patients with active bleeding or bleeding tendency;
- •Pregnant or lactating women;
- •The researchers think inappropriate.
研究组 & 干预措施
Apatinib+Paclitaxel+Cisplatin+RT
Experimental
Apatinib：250mg,po,qd, d1-35; Paclitaxel：50mg/m2 iv, d1，8，15，22，29; Cisplatin: 30mg/m2 iv, d1，8，15，22，29; Radiotherapy：41.4Gy/23f , 1.8Gy/f，5 f/w
干预措施: Apatinib,Paclitaxel,Cisplatin,RT (Combination Product)
结局指标
主要结局
The pathological complete response rate(pCR)
时间窗: within 3 weeks after surgery
The lesion disappeared completely by pathology
次要结局
- Disease-free survival(DFS)(3 years)
- Adverse events Toxicity(3 years)
- Overall survival (OS)(1year)
- R0-resection rate(within 3 weeks after surgery)
研究者
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