Biomarker study of FTD/TPI and Bevacizumab as Salvage line chemotherapy for colorectal cancer. - TAS-CC5 Study

Takeshi Yamada0 个研究点目标入组 105 人开始时间: 2023年2月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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)Patients with unresectable advanced recurrent colorectal cancer who have become refractory or intolerant to fluoropyrimidine anticancer drugs, oxaliplatin, irinotecan, and angiogenesis inhibitors (bevacizumab, ramucirumab, or aflibercept).
•5)20< and 80> years old
•6)ECOG performance status of 0 or 1
•7)With measurable lesions according
•8)ability to tolerate oral drug administration
•9)a life expectancy of at least 3 months
•10)Patient who has adequate main organ functions in tests within 14 days beforeenrollment
•leukocyte >3,000/mm3
•neutrophil >1,000/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 <5x Upper limit of normal (ULN).
•serum creatinine <1.5 mg/dL
•Peripheral neuropathy Diarrhea and NonHaematotoxicity 11)gave written informed consent

•1)contraindications for FTD/TPI and Bevacizumab
•2)previously received chemotherapy with FTD/TPI
•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)Comorbidity or history of heart failure
•8)gastrointestinal ulcer or bleeding
•9)previous hemoptysis
•10)Clinical or radiological evidence of CNS metastases
•11)Current or previous (within the last 6 months) history of GI perforation
•12)Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study
•13)ongoing treatment with anticoagulant
•14)Synchronous or metachronous multiple malignancy within the last 5 year disease free interval
•15)Under continuous steroid administration
•16)decision of unsuitable for this study by the investigator

发起方

Takeshi Yamada