ACTRN12618001017213招募中未知
The Safety And Feasibility of Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) in the treatment of Unresectable Disseminated Peritoneal Malignancy
Department of Surgery, University of Adelaide, TQEH0 个研究点目标入组 112 人开始时间: 2018年6月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Adult patients (> 18 years of age)
- •Clinical confirmation of peritoneal carcinomatosis from gastric, pancreatic, appendiceal or colorectal cancer.
- •Previous histopathological evidence of neoplastic disease is available.
- •Patients must have demonstrated resistance to or lack of response to already approved and available systemic chemotherapy.
- •Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
排除标准
- •Extra-abdominal metastatic disease, excluding low volume lung metastasis.
- •Bowel obstruction requiring nasogastric tube or percutaneous endoscopic gastrostomy
- •Chemotherapy, radiotherapy or surgery within the last 4 weeks prior to dosing
- •History of allergic reaction to platinum containing compounds or doxorubicin
- •Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias
- •Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system
- •Large volume ascites (greater than one litre).
- •Any chronic medical or psychiatric condition that in the option of the investigators would make the subject unsuitable for the study or prevent compliance with study protocol procedures.
研究者
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