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临床试验/NCT01822210
NCT01822210已完成2 期

Botulinum Toxin (BOTOX) for Stomach Cancer Treatment

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
7
试验地点
1
主要终点
Change of tumor volume in the stomach.

研究概览

简要总结

Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Botox

Experimental

Injection of Botox in the tumor and surrounding stomach wall.

干预措施: Botox (Drug)

结局指标

主要结局

Change of tumor volume in the stomach.

时间窗: 8 weeks and 20 weeks

Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).

次要结局

  • Toxicity(8 weeks)
  • performance status(20 weeks)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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