NCT02518529已完成2 期
An Open, Multi-centre Study to Determine the Tolerability, Safety and Antibody Response Resulting From G17DT at 250mcg at Weeks 0, 2 and 6 With a Booster of 125mcg or 250mcg Given to Patients With Stage I - III Gastric Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Measurable Gastrin-17 Antibody Titer
研究概览
简要总结
Open-label, multicenter study to assess 250µg/0.2ml G17DT injection at weeks 0, 2 and 6. At or after week 20 and up to and including week 44. Subjects who raised antibodies to G17DT were given an additional dose of 125µg/0.1ml or 250µg/0.2ml G17DT between weeks 20-44 (study duration 52 weeks).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had had curative resection for histologically confirmed Stage I, II, or III gastric carcinoma or carcinoma of the oesophagogastric junciton.
- •Male or female patients over 18 years of age.
- •Patients with a life expectancy of at least four months.
- •Karnofsky index for performance status of >70%
- •Patients must have given written informed consent.
排除标准
- •Gastric or junctional surgery within three weeks of baseline (week 0) or gastric or junctional surgery anticipated in the study period.
- •History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix.
- •Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of chemotherapy or immunotherapy.
- •Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of radiotherapy or any other anti-cancer therapy.
- •Previous use (within the four weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of immunosuppressants, including systemic corticosteroids.
- •Known immunodeficiency.
- •Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration.
- •Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or up to week 16 during this study.
- •Previous G17DT treatment.
- •Haematological indicators:
- •Haemoglobin <10.0g/dl Neutrophils < 2.0 x 109/l Platelets <100 x 109/l
研究组 & 干预措施
250µg dose treatment
Experimental
Subjects were treated with a 250mcg/0.2ml G17DT injection at weeks 0, 2 and 6.
干预措施: G17DT (Biological)
结局指标
主要结局
Measurable Gastrin-17 Antibody Titer
时间窗: Up to Week 52
次要结局
- Overall Survival from date of randomization to death or end of study(Up to December 2002)
- Injection tolerability(Up to Week 52)
研究者
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