EUCTR2009-011337-27-AT进行中（未招募）1 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 - Gastric 4
AGMT0 个研究点目标入组 0 人开始时间: 2010年2月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed informed consent
- •untreated, histologically confirmed, non-metastasizing, resectable gastric or esophageal adenocarcinoma
- •KRAS wild type tumor
- •T2-4 NX M0 disease – see appendix 5
- •ECOG performance status 0 or 1
- •Patiente 18 to 65 years old
- •Ability to understand and comply with requirements of study protocol and trial partici-pation
- •Patients of either sex are eligible for study entry. Women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception (e.g. intrauterine device (IUD), birth control pills, or barrier device) during treatment and for 6 months following the last dose of Pmab.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or breast feeding women.
- •Women of child-bearing potential and men not willing to use effective contraception during treatment and for 6 months after the end of treatment with Pmab
- •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.
- •Active bacterial, viral or fungal infection (including acute or chronic-active infection with HBV or HCV).
- •Arterial or venous thromboembolism within 6 months before enrollment
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=1 year before enrollment
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
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