A phase II study of Trastuzumab with S-1 plus Oxaliplatin for HER2 positive advanced gastric cancer (Herceptin with SOX for Gastric Cancer) (HIGHSOX study)

未提供0 个研究点目标入组 75 人开始时间: 2015年6月24日最近更新: 2020年9月30日

试验速览

暂无简介。

•Histologically proven advanced or recurrent adenocarcinoma
•No prior therapy except for adjuvant chemotherapy of S-1 finished more than 6 months before
•With measurable lesions by RECIST version 1.1
•HER2 positive (IHC 3+ or IHC 2 + and ISH +)
•Age 20 - 75
•ECOG PS 0 or 1
•No symptomatic cerebral lesions
•Adequate organ functions
•LVEF (Left Ventricular Ejection Fraction) > 50 %
•No abnormal findings in ECG
•Possible for oral intake
•With an expected survival longer than 3 months
•Wth written Informed consent

•Could not administrate S-1, oxaliplatin, and trastuzumab
•Pregnant and/or nursing women or men who wish to have children in future
•With active infectious disease
•HBs antigen positive
•With a history or current symptoms of heart failure, uncontrollable arrhythmia, angina pectoris, valvular disease, and uncontrollable hypertension
•With interstitial pneumonia, pulmonary fibrosis, heart failure, renal failure, hepatic failure, uncontrollable diabetes mellitus
•With dyspnea at rest
•With active bleeding from gastric cancer / ulcer
•With severe diarrhea
•With severe sensory neuropathy
•With active double cancers excluding carcinoma in situ and/or prior curative cancer with relapse free for more than 5 years
•Under meditation of flucytosine, phenytoin,or warfarin
•Under continuous meditation of steroids
•Judged to be unfit to participate in this study by investigator

Response Rate

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发起方

未提供