JPRN-jRCT2080223930暂停1 期
A Phase I Multicenter Study of Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- AstraZeneca
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •World Health Organization (WHO)/ECOG performance status of 0 or 1
- •-Body weight > 30 kg at enrollment and treatment assignment
- •-At least 1 measurable lesion, not previously irradiated
- •-No prior exposure to immune-mediated therapy (including therapeutic anticancer vaccines)
- •-For patients with oropharyngeal HNSCC HPV status has to be known
排除标准
- •Patients with simultaneous primary malignancies or bilateral tumors
- •-Active or prior documented autoimmune or inflammatory disorders
- •-Brain metastases or spinal cord compression
- •-Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies)
- •-Has a paraneoplastic syndrome (PNS) of autoimmune nature
- •-HNSCC cohort: Head and neck cancer that does not include unresectable, locally advanced cancer of oral cavity, larynx, oropharynx or hypopharynx. HNSCC of unknown primary are also excluded
- •-NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology
- •-SCLC cohort: Extensive-stage SCLC
研究者
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