Phase II Study of Liposomal Paclitaxel With Nedaplatin as First-line in Advanced or Recurrent Esophageal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal Carcinoma
详细描述
The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal Carcinoma.Patients receive Liposomal Paclitaxel 175mg/m2 and Nedaplatin 80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •histological confirmed advanced metastatic or recurrent esophageal cancer
- •age between 18 and 80 years
- •ECOG performance status of 0 to 2
- •life expectancy ≥ 12 weeks
- •has evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
- •at least one prior chemotherapy regimen
- •adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3
- •platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL
- •adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min,
- •adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN.
排除标准
- •other primary malignancy
- •symptomatic central nervous system metastasis
- •pregnancy or lactation
- •cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure
- •ongoing infection
研究组 & 干预措施
Treatment group
patients received Liposomal Paclitaxel and Nedaplatin every 21 days until the presence of progressive disease or unacceptable toxicity
干预措施: Liposomal Paclitaxel (Drug)
Treatment group
patients received Liposomal Paclitaxel and Nedaplatin every 21 days until the presence of progressive disease or unacceptable toxicity
干预措施: Nedaplatin (Drug)
结局指标
主要结局
Response rate
时间窗: from date of baseline measured to date of first CT evaluation，Up to 3 months
To assess the response rate of Liposomal Paclitaxel and Nedaplatin in patients with pretreated advanced or recurrent esophageal carcinoma. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
次要结局
- overall survival(baseline to date of death from any cause，up to 2 approximately years)
- Number of Participants With Adverse Events (Toxicity)(Up to 30 days post last dose)
- progression-free survival(from date of baseline to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
研究者
Ruihua Xu
professor
Sun Yat-sen University