ACTRN12609000260224招募中1 期
In patients with malignant mesothelioma (MM) and non-small cell lung cancer (NSCLC) does low-dose iterative cyclophosphamide in combination with conventionally dosed pemetrexed-based chemotherapy decrease regulatory T cell numbers and increase antigen-specific and non-specific cellular immunity.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 33
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 locally advanced or metastatic non-small cell lung cancer (NSCLC) or malignant mesothelioma (MM) planned for treatment with a pemetrexed-containing regimen.
- •Treatment of advanced disease with palliative intent.
- •First or second line treatment.
- •Measureable or evaluable disease as defined by the RECIST criteria (NSCLC) or Modified RECIST (MM).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
排除标准
- •History of severe autoimmune disease.
- •Radiotherapy to all areas of measureable disease.
- •Previous or concurrent malignancy diagnosis (except curatively-treated basal cell carcinoma (BCC) of skin, carcinoma in situ of cervix) unless treated with curative intent more than 5 years before enrolment.
- •Concomitant requirement for oral corticosteroids for more than 5 days of each treatment cycle.
- •Concomitant treatment with other investigational agents or immunotherapy.
- •Pregnant or breast feeding.
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