JPRN-jRCTs031180424已完成2 期
TAS-102 and Bevacizumab as Salvage line chemotherapy for colorectal cancer - TAS-CC4 Study
Yamada Takeshi0 个研究点目标入组 45 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
In conclusion, biweekly TAS-102-and-bevacizumab combination therapy has efficacy equivalent to conventional TAS-102-and-bevacizumab combination therapy, but with less neutropenia. This novel treatment can improve survival of colorectal cancer patients who receive this as third-line chemotherapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •1)Histologically proven colorectal cancer
- •2)patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s)
- •3)treatment history of two or more regimens for metastatic colorectal cancer, and who has confirmed PD in imaging study
- •4)20<= and 80>= years old
- •5)ECOG performance status of 0 or 1
- •6)With measurable lesions according
- •7)ability to tolerate oral drug administration
- •8)a life expectancy of at least 3 months
- •9)Patient who has adequate main organ functions in tests within 14 days beforeenrollment
- •-leukocyte >=3,500/mm3
- •-neutrophil >=1,500/mm3
- •-platelet >=75,000/mm3
- •-haemoglobin concentorarion >=8.0 g/dL
- •-serum total bilirubin level <=1.5 mg/dLserum creatinine <=1.5 mg/dL
- •-serum AST and ALT levels <2.5x Upper limit of normal (ULN).
- •-serum creatinine <=1.5 mg/dL
- •-Peripheral neuropathy<=grade2
- •-Diarrhea and NonHaematotoxicity =10)gave written informed consent
排除标准
- •1)contraindications for TAS-102 and Bevacizumab
- •2)previously received chemotherapy with TAS-102
- •3)severe drug allergy
- •4)pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy.
- •5)patient who has important clinical complications(symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.)
- •6)other active malignancies
- •7)have pleural effusion and ascitic fluid with the treatment
- •8)Comorbidity or history of heart failure
- •9)gastrointestinal ulcer or bleeding
- •10)previous hemoptysis
- •11)Clinical or radiological evidence of CNS metastases
- •12)Current or previous (within the last 6 months) history of GI perforation
- •13)Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study
- •14)ongoing treatment with anticoagulant
- •15)Synchronous or metachronous multiple malignancy within the last 5 year disease free interval
- •16)Under continuous steroid administration
- •17)decision of unsuitable for this study by the investigator
研究者
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