NCT02011594撤回2 期
Phase II Study of Maintenance Treatment of Nimotuzumab Versus No Maintenance for Advanced Esophageal Carcinoma
Zhejiang University2 个研究点 分布在 1 个国家开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- PFS (Progression free survival)
研究概览
简要总结
There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy. However, whether maintenance therapy of nimotuzumab provides benefit to advanced esophageal cancer patients is not known.
详细描述
We design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology.
- •The sample size estimate: 20 cases per arm.
- •Males or females aged ≥18 years, < 75 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Life expectancy ≥12 weeks.
- •Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
- •Adequate bone marrow, renal, and liver function are required.
- •Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- •Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.
排除标准
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- •Allergy to anti-EGFR antibody.
- •Female subjects should not be pregnant or breast-feeding.
- •Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function: total bilirubin < 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
- •Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
研究组 & 干预措施
Arm A
Experimental
Nimotuzumab
干预措施: Nimotuzumab (Drug)
Arm B
Placebo Comparator
Placebo (normal saline)
干预措施: Placebo (Drug)
结局指标
主要结局
PFS (Progression free survival)
时间窗: 12 months
次要结局
- Objective Response Rate(6 months)
- Overall survival (OS)(12 months)
- Disease control rate (DCR)(12 months)
研究者
Qiong Zhao
Chief of Department of Thoracic Oncology
Zhejiang University
研究点 (2)
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