JPRN-UMIN000016439已完成2 期
Phase II Clinical Study Evaluating the Efficacy and Safety of Cetuximab Rechallenge in Patients with Wild-Type RAS, Unresectable, Progressive/Recurrent Colorectal Cancer Refractory to Fluoropyrimidines, Oxaliplatin, Irinotecan, Cetuximab and Bevacizumab: The E-Rechallenge Trial - The E-Rechallenge Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
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) Patients with severe diarrhea (watery stools). 2) Patients with active infection (requiring treatment with intravenous antibiotics or antibacterial agents, antifungal agents, or antiviral agents) or with HIV infection. 3) Patients with fluid in a body cavity (such as a pleural effusion, ascites, or pericardial effusion) that requires treatment. 4) Patients with clinical evidence of coronary artery disease, myocardial infarction within 12 months before enrollment, or a poorly controlled arrhythmia or cardiac dysfunction. 5) Patients with pulmonary fibrosis, an acute lung disorder, or interstitial pneumonitis (or a history of any of these conditions). 6) Patients with intestinal paralysis or obstruction. 7) Patients with jaundice or hepatic failure. 8) Patients on treatment with atazanavir sulfate. 9) Patients with uncontrolled diabetes mellitus, malignant hypertension, or hypercalcemia. 10) Patients with symptomatic brain metastasis. 11) Patients with a history of hypersensitivity to cetuximab or irinotecan. 12) Patients with synchronous double cancer or with metachronous double cancer and a disease-free interval <=5 years (except for skin cancer and early gastrointestinal cancer likely to be cured by endoscopic mucosal resection). 13) Men who are unwilling to use contraception, and pregnant women, nursing mothers, women with positive pregnancy test, or women unwilling to use contraception. 14) Other patients who the investigator judges to be unsuitable as subjects of this study.
研究者
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