NCT01351038终止2 期
A Two Stage Multicenter Phase II Trial of Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma
Arbeitsgemeinschaft medikamentoese Tumortherapie6 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2011年5月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 43
- 试验地点
- 6
- 主要终点
- Efficacy
研究概览
简要总结
This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma
- •T2-4 NX M0 disease
- •ECOG performance status 0-1
- •adequate hematological status
- •adequate renal function
- •adequate hepatic function
- •adequate metabolic function
排除标准
- •pregnant or breast feeding women
- •previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
- •arterial or venous thromboembolism within 6 months before enrollment
- •clinically significant cardiovascular disease within 1 year before enrollment
- •history of interstitial lung disease
研究组 & 干预措施
treatment
Experimental
3 cycles(repeated q21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Capecitabine 500mg/m² bid d1-d21 Panitumumab 9mg/kg i.v. d1
干预措施: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab (Drug)
结局指标
主要结局
Efficacy
Proportion of patients with T0 ant T1 disease after neoadjuvant combined chemoimmunotherapy
Safety
Proportion of patients with grade 4 diarrhea
次要结局
- Histopathological response
- overall survival after one year
- Progression free survival after one year
- Proportion of patients completing 3 treatment cycles
- Safety
研究者
研究点 (6)
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