EUCTR2016-004727-23-GB进行中（未招募）1 期
A Trial of Intra-pleuraL OK-432 Therapy in mesothelioma (TILT): A feasibility study using the ‘trial within a cohort’ methodology - TILT
orth Bristol NHS Trust Research & Innovation0 个研究点目标入组 45 人开始时间: 2018年5月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To participate in TILT patients must meet all of the following inclusion criteria:
- •Histological or cytological diagnosis of mesothelioma
- •Enrolled in ASSESS-meso and has given consent to be considered for and be randomly selected for future trials
- •Indwelling pleural catheter (IPC) in situ that has drained more than 50ml of fluid on previous 3 drainages OR willing to have an IPC and has a pleural effusion suitable for IPC insertion
- •No chemotherapy in preceding 4 weeks and none planned in subsequent 4 weeks
- •Performance status =2, or PS 3 and felt clinically suitable for trial
- •Predicted survival =12 weeks from enrolment
- •Able to give written informed consent & meet trial requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •To be eligible for TILT, participants must have none of the following exclusion criteria:
- •No indwelling pleural catheter (IPC) in situ, and has contra-indication to IPC insertion
- •Clinico-radiological diagnosis of mesothelioma
- •Trapped lung with <50% pleural apposition on x-ray
- •Moderately heavy or heavily loculated pleural effusion
- •Known immunodeficiency or immuno-suppressive medication
- •Intercurrent infection (pleural or elsewhere) or clinical signs of sepsis
- •Known sensitivity or allergy to OK432 or penicillin
- •Previous treatment with immunotherapy
- •Currently enrolled in any other interventional clinical trial
- •Brain metastases or CNS involvement of mesothelioma
- •Pregnancy or lactation, current or planned during the study period
- •Any other factor that, in the opinion of the Chief Investigator, would mean participation in the study would be contraindicated
研究者
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