EUCTR2020-000725-27-DK进行中(未招募)1 期
Intratumoral Influenza Vaccine for Early Colorectal Cancer
Center for Surgical Science, Department of Surgery, Zealand University Hospital0 个研究点目标入组 30 人开始时间: 2020年4月24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
- 入组人数
- 30
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
- •Patients must be mentally capable of understanding the information given.
- •Patients must give written informed consent.
- •Clinically suspected or histologically verified malignant tumor of the rectum or sigmoid colon.
- •Tumor described as passable at index endoscopy.
- •Men or women aged at least 18 years.
- •Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection.
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
- •Ongoing immunosuppressive treatment.
- •Concurrent treatment with an investigational medicinal product.
- •Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
- •Advanced tumor stages, clinical UICC stage IV.
- •Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
- •Acute surgical resection.
- •Any previous allergic reaction to influenza vaccine or constituents, egg and chicken proteins, neomycin, formaldehyde or octoxinol-9
- •Acute febrile illness
- •Acute infectious disease
- •Influenza vaccine administered within 30 days before study inclusion
研究者
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