JPRN-jRCTs051190076招募中1 期
Clinical safety and efficacy of neo-adjuvant combination chemotherapy of Tranilast in advanced esophageal squamous cell carcinoma: phase I/II study - TNAC
Shiozaki Atsushi0 个研究点目标入组 59 人开始时间: 2019年11月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 59
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
- >= 20age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •1) Pathologically proven esophageal squamous cell carcinoma
- •2) Clinically diagnosed Stage II or Stage III esophageal squamous cell carcinoma patients in Japanese Classification of Esophageal Cancer, 11th edition
- •3) A case who was judged to be able to undergo radical esopagctomy under the general anesthesia
- •4) Age between 20 and 74 years old
- •5) A cases with ECOG Performance status 0,1 or 2
- •6) an essentially normal clinical laboratory profile
- •(serum creatinine: <=1.2 mg /dl; (creatinine clearance or CCr) >=60 ml/minute;
- •total serum bilirubin: <=1.2 mg /dl; aspartate aminotransaminase or AST and
- •alanine aminotransaminase or ALT: no higher than twice upper limit of normal value defined in our institution; white blood cell count: >=4,000 /mm3; haemoglobin: >=10g /dl; platelet count: >=100,000 /mm3
- •7) A case that can take medicine.
- •8) Oral and written informed consent obtained before registration
排除标准
- •1) A history of chemotherapy or radiotherapy 1 year before treatment begins
- •2) Tumor with active bleeding
- •3) A case with histories of acute myocardial infarction, severe angina, congested heart failure, cerebrovascular disease, or pulmonary thrombosis within 6 months before registration
- •4) A case with uncontrolled asthma
- •5) A history of laparotomy or trachotomy within 4 weeks before treatment begins
- •6) A case with allergy of tranilast
- •7) A female with a possibility of pregnancy, breastfeeding to infant, and desire to bear children
- •8) A case judged as inappropriate for the present clinical trial by the chief researcher
- •9) A case that take some similar drugs to tranilast
- •10) A case with transfusion within 14 days before registration
- •11) Current medication of warfarin
研究者
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