NCT02677597Unknown3 期
An Open, Multicenter, Randomized Phase III Clinical Study on Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven primary thoracic esophageal squamous cell carcinoma
- •Not suitable for surgery or radio or chemical therapy
- •Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
- •18~70 years
- •Life expectancy of ≥ 3 months
- •WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L
- •TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL
- •Scr≥60 mL/min
- •Normal electrocardiogram (ecg)
- •Can normal oral drugs
- •Signed written informed consent
排除标准
- •Breast-feeding or pregnant women, no effective contraception if risk of conception exists
- •Chronic diarrhea, enteritis, intestine obstruction which are not under control
- •Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
- •A second primary tumor (except skin basal cell carcinoma)
- •The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
- •With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
- •With bleeding tendency
- •Has inherited bleeding evidence of physical or blood coagulation disorder
- •With clear chemotherapy drug allergy
- •Other researchers believe that patients should not participate in this testing
研究组 & 干预措施
Cisplatin Combined With S-1
Experimental
Cisplatin 75mg/m2 ivgtt d1 S-1 BSA<1.5 50mg bid，BSA≥1.5 60mg bid po d1-14
干预措施: Cisplatin Combined With S-1 (Drug)
Cisplatin Combined With Paclitaxel
Experimental
Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h
干预措施: Cisplatin Combined With Paclitaxel (Drug)
结局指标
主要结局
PFS
时间窗: Since the date of random to disease progression or any cause of death，the average time is 2 years
次要结局
未报告次要终点
研究者
Chang Jian Hua
Chief Physician
Fudan University
研究点 (1)
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