Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Progression free survival(PFS)
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.And,albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy,and with greater concentration in tumor tissue compared with normal tissues.So,The objective of this single-arm phase II trial was to evaluate the benefit of nimotuzumab plus nab-paclitaxel and cisplatin in patients with advanced esophageal carcinoma.
详细描述
In the past decade, clinical trials have evaluated the role of chemotherapy, radiation, or both, for patients with advanced esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, Chemotherapy became one of the treatment strategies for advanced esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, the investigators conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin for patients with advanced 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 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.
- •Males or females aged ≥18 years, < 75 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Life expectancy ≥12 weeks.
- •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.
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
Nimotuzumab & nab-paclitaxel & cisplatin
Nimotuzumab: 200mg,IV once a week during chemotherapy.
Nab-paclitaxel: 125mg/m2,(IV over 30 min) (days 1 and 8) on 21 day cycle
Cisplatin: 75mg/m2,IV on 21 day cycle
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
Progression free survival(PFS)
时间窗: 12 months
次要结局
- Objective Response Rate(From date of treatment until the date of progression, assessed up to 2 months)
研究者
Qiong Zhao
Chief of Department of Thoracic Oncology
Zhejiang University