NCT02118077已完成3 期
A Prospective, Randomized, Double-blind, Placebo-controlled, Group Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 主要终点
- Patient Survival
研究概览
简要总结
Compare the effect of G17DT with that of placebo on the survival of subjects with advanced pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects with a histologically or cytologically confirmed diagnosis of pancreatic carcinoma, who were not eligible for tumor resection with curative intent (i.e., Stage II, III, or IV disease)
- •Male or female subjects over 18 years of age
- •Subjects with a life expectancy of at least 2 months
- •KPS score of ≥60%
- •Written informed consent
排除标准
- •Previous, concomitant, or anticipated use (up to Week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy
- •Previous (during the 4 weeks before the study), concomitant, or anticipated use (up to Week 12) of immunosuppressants. However, for systemic [i.e., oral or injected] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.)
- •History of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix
- •Known immunodeficiency
- •Females who were pregnant, planning to become pregnant, or lactating (Women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.)
- •Subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to Week 12 during this study
- •Previous G17DT treatment
- •Hematological indicators as follows:
- •Hemoglobin <9.5 g/dL
- •Neutrophils <2.0 × 109/L
- •Platelets <100 × 109/L
- •Any other condition or circumstance that might have the following results:
- •Worsen if the subject participated in the study
- •Reduce the subject's ability to comply with the protocol
- •Confound the interpretation of the study results
结局指标
主要结局
Patient Survival
时间窗: Up to week 134
The vital status of each patient was followed until death or end of the study.
Number of Participants with Serious and Non-Serious Adverse Events
时间窗: up to week 134
Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit.
次要结局
- Objective tumor response(Weeks 24 and 52)
研究者
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