JPRN-UMIN000032671已完成1 期
Phase Ib study of combination therapy with Cisplatin, Irinotecan, and Ramucirumab for extensive-disease small-cell lung cancer - Phase Ib study for SCLC (CIRCLE study)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
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 74years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Symptomatic brain metastases 2)Major surgery within 28 days or have subcutaneous venous access device placement within 7 days, prior to registration 3)Active infection requiring systemic treatment 4)Body temperature >= 38 degrees Celsius 5)Congestive heart failure with NYHA Class II to IV, or symptomatic, uncontrollable arrhythmia 6)Cirrhosis with Child-Pugh classification B score or more severe, or hepatic encephalopathy history 7)Poorly controlled hypertension 8)Hemoptysis history, more than one-half teaspoonful, within 2 months 9)Vasculitis, grade 3 or above gastrointestinal hemorrhage, or clinically serious hemorrhage within 3 months 10)Gastrointestinal/bowel perforation, gastric ulcer, diverticulum, or fistula within 6 months 11)Poor wound healing or bone fracture within 28 days 12)Radiographic major blood vessel invasion or encasement by cancer 13)Radiographic intratumoral cavitation 14)Active double cancer 15)Myocardial infarction, unstable angina pectoris, cerebrovascular accident, or TIA within 6 months. Any events caused by arterial thromboembolism within 6 months. 16)Receiving long-term treatment of NSAIDS, antiplatelet drug within 7 days before the initial administration of the study drug. Aspirin less than 325mg per day is acceptable. 17)Participant of other clinical studies with other drugs, unapproved drugs and medical devices, or clinical studies that are considered scientifically or medically incompatible with this study 18)Serious hypersensitivity against platinum-based drugs or irinotecan 19)Continuous systemic administration of high-dose steroids equivalent to prednisolone >= 10 mg/day (oral or intravenous), immunosuppressants. Patients who are taking oral steroids equivalent to prednisolone <10 mg/day are acceptable. 20)Interstitial pneumonia, pulmonary fibrosis or severe emphysema 21)Positive HBs antigen 22)Pregnant or lactating women or women willing child-bearing 23)Psychiatric disease 24)The investigator judged ineligible with any reason
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