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临床试验/ACTRN12620001264976
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

发起方
I-MED Radiology

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