NCT00044031已完成3 期
Prospective, Randomized, Controlled, Double-Blind, Multi-National, Multi-Center Study of G17DT Immunogen in Combination With Gemcitabine Versus Placebo in Combination With Gemcitabine in Previously Untreated Subjects With Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Protocol No. PC4)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 394
- 主要终点
- Survival
研究概览
简要总结
This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection
- •Life expectancy of at least 3 months
- •Functional status by Karnofsky Index of at least 70
排除标准
- •Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy
- •Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
- •Immunodeficiency
- •Bone marrow transplant within past year
- •Brain metastasis
研究组 & 干预措施
B
Placebo Comparator
Placebo (immunogen vehicle) combined with gemcitabine.
A
Experimental
500 µg G17DT immunogen combined with gemcitabine.
干预措施: G17DT Immunogen (Biological)
结局指标
主要结局
Survival
时间窗: Up to 12 months
次要结局
- Number of Participants with Serious and Non-Serious Adverse Events(Up to 12 months)
研究者
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