ACTRN12620001264976招募中1 期
Transarterial Chemoperfusion Treatment in Patients with Unresectable Pleural Mesothelioma: A Feasibility Study
I-MED Radiology0 个研究点目标入组 6 人开始时间: 2020年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
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
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Histologically or cytologically confirmed MPM.
- •Tumour/s assessed as inoperable or refuses surgery.
- •The predominant burden of disease lies in an arterial distribution which is accessible for transarterial chemoperfusion treatment.
- •Failure to respond to first line standard of care chemotherapy.
- •Have measurable disease, by computed tomography (CT) as per modified Response Evaluation Criteria in Solid Tumours (RECIST) for mesothelioma.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, imaging studies, and other requirements of the study.
- •An ECOG performance status score <3.
- •Patient is expected to survive and be available for follow up for at least 12 months.
- •Patients must have private health insurance to be included in this trial and eligible for treatment at The Wesley Hospital.
排除标准
- •Large pulmonary-systemic shunting of tumour vasculature, as demonstrated on preliminary angiogram.
- •Patients who have had chemotherapy within 4 weeks prior to entering the study.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, methotrexate, gemcitabine or other agents used during the study.
- •History of moderate and severe allergic reaction to intravenous iodinated contrast media is not a contraindication to the study.
- •Involvement in trials with other investigational agents.
- •Patient with synchronous primary tumours requiring other therapy.
- •Uncontrolled intercurrent illness including, but not limited to, renal dysfunction, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Women who are pregnant or lactating.
研究者
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