JPRN-jRCTs031180382已完成2 期
TAS-102 and Bevacizumab as salvage line chemotherapy for colorectal cancer - SOAC1701
Matsubara Hisahiro0 个研究点目标入组 7 人开始时间: 2019年3月19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
- 7
研究概览
简要总结
The patients were enrolled from August 2019 to August 2020 from two centers. TAS-102+Bevacizumab as 2nd line treatment for patients with unresectable colorectal cancer who were 1: 20-74 years old and PS2, 2: 75 years old or older and PS0 or 1, 3: 20 years old or older and refractory or intolerant to irinotecan and oxaliplatin. The decision was made to discontinue the study on November 1, 2021 due to insufficient number of enrolled patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) patient with any of the fllowing
- •(1) patient who is 20 years or older, and considered to be intorelant to irinotecan or oxaliplatin.
- •(2) Patient who is 20 to 74 years old and with an ECOG Performance Status of 2
- •(3) Patient who is over 75 years old and with an ECOG Performance Status of 0 or 1
- •2) patient who has histologically or cytologically confirmed colorectal adenocarcinoma
- •3) patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s)
- •4) patient who has a treatment history of one or more regimens for metastatic colorectal cancer, and who is refractory or intolerant to them
- •5) patient who has at least one measurable lesion in imaging study
- •6) patient with ability to tolerate oral drug administration
- •7) patient who has adequate main organ functions in tests within 14 days before enrollment
- •(1) WBC >= 3500/mm3
- •(2) neutrophil count >=1,500/mm3
- •(3) platelet count >=75,000/mm3
- •(4) haemoglobin concentorarion >=9.0 g/dL
- •(5) AST, ALT <= 2.5x Upper limit of normal (<= 5.0x when liver metastasis exists)
- •(6) serum total bilirubin level <=1.5 mg/dL (<= 2.0 when liver metastasis exists)
- •(7) serum creatinine <=1.5 mg/dL
- •(8) no active infection
- •(9) Peripheral neuropathy<=grade2
- •(10) Diarrhea and NonHaematotoxicity =8) 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) have pleural effusion and ascitic fluid with the treatment
- •7) previous hemoptysis (over 25ml of fresh blood)
- •8) current or previous (within the last 6 months) history of GI perforation
- •9) patient with thrombosis (within the last 6 months)
- •10) patient with bleeding tendency
- •11) synchronous or metachronous multiple malignancy within the last 5 year disease free interval
- •12) dicision of unsuitable for this study by the investigator
研究者
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