JPRN-UMIN000032801已完成1 期
Phase I study of TAS-116 in combination with Nivolumab in patients with progressive or metastatic solid cancer - TAS116nivo_study
ational Cancer Center Hospital East0 个研究点目标入组 48 人开始时间: 2018年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Received systemic chemotherapy, radiotherapy, surgery, hormonal therapy, immunotherapy within 2weeks prior to enrollment. 2) Patients with therapeutic history of TAS-116 3) Patients with a history of acute coronary syndrome (including myocardial infarction and unstable angina), coronary angioplasty, or stent placement within 6 months prior to enrollment 4) Patients with a large amount of pleural effusion or ascites requiring drainage 5) Patients with grade 3 or higher active infections according to CTCAE v 4.0 6) Patients with symptomatic brain metastases 7) Patients with gastrointestinal obstruction or incomplete obstruction 8) Patients with interstitial lung disease with active symptoms or signs 9) Either HIV antibody, HBs antigen or HCV antibody test is positive. Positive HBs antibody or HBc antibody test with HBV-DNA quantification above threshold. 10) Patients with autoimmune disease complications or a history of chronic or recurrent autoimmune disease 11) Patients requiring systemic adrenocortical hormone or an immunosuppressant, or patients received these treatments within 14 days prior to enrollment 12) Patients with a history or finding of congestive heart failure of NYHA classification III or higher 13) Patients with seizure disorder requiring drug treatment 14) Patients with a history of hypersensitivity to investigational drugs, similar drugs or excipients 15) Pregnant women, lactating women or possibly pregnant women 16) Patients with corrected eyesight of both eyes less than 0.5 (using the Universal Testing Power Table)
研究者
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