JPRN-jRCT2080223982已完成2 期
A phase II study of Ad-SGE-REIC
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
The study was discontinued during the study due to below the pre-defined threshold of median PFS for judgement of the efficacy. While there was one subject with a partial response (PR) in the best overall response, there was no overall trend toward tumor reduction with the product. Safety was generally within the expected safety profile.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Key inclusion criteria
- •Pathologically confirmed malignant pleural mesothelioma which isunresectable
- •Patients with one or more measurable disease
- •Patients who have adequate main organs function
- •Patients who signed written informed consent
排除标准
- •Key exclusion criteria
- •Patients with simultaneous tumor and/or metachronaus tumor (excluding patients with them whose disease-free interval is over 2 years)
- •Active infections
- •Symptomatic brain metastasis requiring treatment
- •Pulmonary fibrosis or interstitial pneumonia
- •Cardiac effusion requiring treatment
- •Comorbidities requiring systemic corticosteroid or an immunosuppressants
研究者
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