ACTRN12623000632695尚未招募Unknown
Imaging biomarkers of response to immunotherapy in malignant mesothelioma
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 40
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
- •To be eligible for inclusion in Stage 1, patient must satisfy ALL of the following:
- •Written informed consent
- •Able to undergo study procedures
- •Life expectancy > 12 weeks
- •Minimum age 18 years, no maximum age
- •Body weight > 30kg
- •Patients with histologically or cytologically confirmed mesothelioma, pleural or peritoneal
- •No prior immune checkpoint therapy
- •Estimated glomerular filtration rate (eGFR) > 60ml/min
- •An Eastern Cooperative Group Oncology Group (ECOG) performance score of 0-2
- •Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •Male or female patients of reproductive potential who are employing an effective method of birth control
- •To be eligible for inclusion in Stage 2, patient must satisfy ALL of the following:
- •Written informed consent
- •Minimum age > 18, no maximum age
- •Body weight > 30kg
- •Histologically confirmed malignant pleural mesothelioma
- •Planned to undergo systemic treatment incorporating checkpoint blockade for their disease
- •eGFR > 60ml/min
- •ECOG performance status 0-1
- •Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •Male or female patients of reproductive potential who are employing an effective method of birth control
排除标准
- •Patients will be excluded from the Stage 1 study if ANY of the following apply:
- •Currently receiving chemotherapy or radiotherapy
- •Pregnant or breastfeeding at the time of study enrolment
- •Inadequate English language to complete study outcome measures
- •Geographically inaccessible for follow-up
- •Less than 18 years of age
- •Prior immune checkpoint inhibitor therapy
- •Known sensitivity or allergy to any study agents
- •Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
- •Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
- •Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
- •Patients will be excluded from the Stage 2 study if ANY of the following apply:
- •Any previous therapy or condition that precludes treatment of mesothelioma with checkpoint blockade therapy
- •Prior immune checkpoint inhibitor therapy
- •Recent major surgery within 4 weeks prior to entry into the study that would prevent administration of study drug
- •Another concurrent active malignancy which may have the potential to confound imaging findings.
- •Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
- •Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results
研究者
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