JPRN-UMIN000042009已完成未知
A multicenter randomized controlled trial for evaluated the efficacy and safety of TDM-621 - TDM-621 clinical trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 227
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
- •Subjects who met any of the following items at the time of enrollment were excluded from this trial. (1) Patients with local residual recurrence (2) Patients with ulcer in the target lesion (3) Poorly differentiated adenocarcinoma or undifferentiated cancer gastric cancer patients and rectal cancer patients (4) Patients with inflammatory bowel disease including ulcerative colitis (5) Patients with a history of hypersensitivity to peptide or protein products (6) Patients with Grade 2 or higher of Performance status according to the clinical evaluation criteria of cancer chemotherapy (7) Patients with serious liver disease, renal disease, cardiovascular disease, etc. [Assessment of severity of adverse event grade 3 or more in the Common Terminology Criteria for Adverse Events] (8) Patients with a condition in which reticuloendothelial system activity may be decreased such as disseminated intravascular coagulation (9) Patients who are receiving blood coagulation drugs (coagulation promoter = hemocoagulase, etc.), antifibrinolytic drugs (drugs having antifibrinolytic action = tranexamic acid, aprotinin preparation, etc.). However, regardless of the use of antiplatelet drugs, the drug should be discontinued in accordance with the guideline for gastrointestinal endoscopy for patients taking antithrombotic drugs. (10) Patients who are scheduled to undergo heparin replacement for ESD
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