Clinical Efficacy and Safety Assessment of Oxaliplatin and Fluorouraciland, Leucovorin [modified FOLFOX6] in Combination with High-dose Bevacizumab as Second-line Therapy in Patients with Advanced or Recurrent Colorectal Cancer after Failure to Irinotecan. Multicenter Clinical Study. - High-FlierS Study

Third Department of Surgery,Tokyo Medical University0 个研究点目标入组 70 人开始时间: 2013年1月15日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.Hypersensitivity or History of the severe hypersensitivity for Bevacizumab, Fluorouraciland Leucovorin. 2.Prior abdominal irradiation for colorectal cancer. 3.CNS metastases or brain cancer confirmed by imaging (When it is suspected, imaging confirmation is required). 4.Complication of cerebrovascular disease or its symptoms within 1 year. 5.With sever complication (Intestinal paralysis, Intestinal obstruction, Interstitial pneumonitis or Pulmonary fibrosis, Uncontrolled diabetes mellitus, Hypertension, cardiac failure, Renal failure, Liver dysfunction, and so on). 6.With complication of history of Gastrointestinal perforation, Intestinal tract paralysis, or Ileus within 1 year. 7.Massive pleural or Ascites that required drainage. 8.Uncontrolled Peptic ulcer. 9.Uncontrolled Diarrhea. 10.Uncontrolled Infection. 11.Diathesis of Bleeding (history of Hemoptysis, including cavitation and/or necrosis in Lung metastasis confirmed by imaging), Coagulopathy or Abnormality of coagulation factor 12.Administrated Antithrombotic drug or drug affected to Congealing Fibrinogenolysis System within 14 days before enrollment (Except for low-dose of Aspirin.) 13.Active multiple primary cancer. 14.Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 15.With mental disorder or psychological symptoms which disturb registration to this study. 16.Not appropriate for the study at the physician's assessment

发起方

Third Department of Surgery,Tokyo Medical University