Electrochemotherapy for Non-curable Gastric Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (CTCAE)
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 electrochemotherapy for non-curable gastric cancer.
详细描述
This is an explorative, phase I clinical trial. Aim of this study is to establish the safety of electrochemotherapy as a palliative treatment for advanced (non-curable) gastric cancer. The study involves recruitment of 8 patients with histologically verified and non-curable gastric cancer (including Siewert Type II and II). Patients will be recruited from Department of Surgery, Odense University Hospital and from Zealand University Hospital after their case has been reviewed by the multidisciplinary team (MDT). Electrochemotherapy will take place at Department of Surgery, Zealand University Hospital. After the treatment patients will be referred to Odense University Hospital for follow-up. Electrochemotherapy will be performed as an additive treatment to standard oncological care. Patients are treated once and will be followed with endoscopy, biopsies, scans, blood samples and questionnaires after 4-6 weeks and 8-12 weeks with a minimum interval of 4 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 must be mentally capable of understanding the information given.
- •Patients must give written informed consent.
- •Histologically verified gastric cancer (adenocarcinoma, including Siewert Type II and II)
- •Non-curable disease according to MDT decision
- •Age ≥ 18 years.
- •ASA class I-III (Classification of the American Society of Anesthesiology)
- •Thrombocytes ≥ 50 billions/l, INR >1,
- •Medical correction is allowed, e.g. correction of elevated INR by means of vitamin K or administration of freshly frozen plasma.
- •Performance status ECOG/WHO ≤2
排除标准
- •Locally advanced non-metastatic EGJ/GC patients that may become resectable after pretreatment
- •Inability to perform upper endoscopy with attached equipment.
- •Uncorrectable coagulation disorder
- •Patients with ICD or pacemaker units
- •Myocardial insufficiency, defined as NYHA class >2
- •Concurrent treatment with an investigational medicinal product.
- •Renal impairment, defined as GFR <40 ml/min
- •Pregnancy
- •Concurrent inclusion in a medical trial where the intervention may affect safety measures used in the current protocol.
- •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.
- •Acute pulmonary infection.
- •Medical history of severe pulmonary disease.
- •Previous allergic reactions to bleomycin.
- •Previous cumulative dose of bleomycin exceeding 250mg/m2.
研究组 & 干预措施
Treátment group
8 patients are expected to be included in this study. The patients will be treated once with bleomycin in combination with elektroporation
干预措施: Bleomycin (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (CTCAE)
时间窗: 3 months
Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated and graded according to Common Terminology Criteria for Adverse Events (CTCAE).
次要结局
- Tumor volume(3 months)
- Gene expression analysis(3 months)
- Histopathological characterization of tumor biopsies(3 months)
- Quality of life with "The European Organization for Research and Treatment of Cancer quality of life questionnaire" (EORTC QLQ-C30)(3 months)