Calcium Electroporation for Early Colorectal Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation prior to intended curative surgery.
详细描述
This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation as a down staging and immune-response enhancing treatment prior to intended curative surgery. The study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. In total the study will involve 24 patients, of these, 12 patients with rectal cancer and 12 patients with sigmoid colon cancer.
In relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment.
Patients will be followed for one month after the elective surgery.
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 must be mentally capable of understanding the information given.
- •Patients must give written informed consent.
- •Histologically verified adenocarcinoma 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.
- •ASA class I-II (Classification of the American Society of Anesthesiology)
排除标准
- •• Uncorrectable coagulation disorder.
- •Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
- •Patients with ICD or pacemaker units.
- •Ongoing immunosuppressive treatment.
- •Patients with concomitant use of phenytoin.
- •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.
- •Pregnancy
研究组 & 干预措施
Calcium Electroporation treatment
Calcium electroporation for colorectal cancer as a preoperative treatment before elective surgery.
干预措施: Calcium electroporation (Combination Product)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: 42 days
Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used
次要结局
- Histopathological characterization of the tumor(14 days)
- Immunologic infiltration of the tumor tissue after calcium electroporation(14 days)
- Immunoscore classification(14 days)
- Systemic immune response according to cytokine analysis(42 days)
- Systemic immune response according to flow cytometri(42 days)
- Metastatic ability after potentially curable surgery(42 days)
- Cell proliferation as a marker for metastatic ability(42 days)