Phase I/II study of Paclitaxel+Trastuzumab therapy in 2nd line treatment for advanced or recurrent gastric cancer with HER2 positive. - PTX+Tmab(2nd)

Osaka Medical College Hospital0 个研究点目标入组 100 人开始时间: 2013年9月25日最近更新: 2023年10月17日

适应症

试验速览

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•1)With active double cancers whose disease free period is within 5 years. Carcinoma in situ can be excluded. 2)With a history of severe allergy against medicine. 3)With severe diarrhea (more than 4 times/day) or watery stool 4)With body temperature over 38 degrees Celsius and/or infectious disease which needs therapy. 5)With severe myelo-dysfunction, renal dysfunction and/or liver dysfunction. 6)With other severe diseases a)Interstitial pneumonitis, pulmonary fibrosis or severe emphysema b)Renal dysfunction c)Liver dysfunction d)Intestinal paralysis, ileus e)Jaundice f)Uncontrolled DM 7)Serious illness or medical conditions as defined below, a)Patients with a previous history of congestive heart failure b)Unstable angina requiring medication c)Patients with a previous history of transmural infarct d)Uncontrolled hypertension e)Severe heart valve diseases f)Hi-risk uncontrolled arrhythmias g)Patients with left ventricular ejection fraction in the baseline is less than 50% on MUGA (Multi Gated Acquisition Scan) or echocardiography. 8)with HBs(+) 9)Patients whom administered Flucitosine or Athazanavil sulfate 10)Patients whom administered Fenitoin and/or Warfarin 11)General administration of steroids 12)Woman who are pregnant or expect to be pregnant or nursing female 13)Patients whom doctor in chief decides not to register to this study due to psychological disease or symptoms 14)Patients whom doctor in chief decides not to register to this study due to other reasons

发起方

Osaka Medical College Hospital