JPRN-jRCTs051180196已完成2 期
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
Takahari Daisuke0 个研究点目标入组 75 人开始时间: 2019年3月26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
- 75
研究概览
简要总结
Results from this phase 2 study suggest that trastuzumab with SOX is well tolerated and has promising efficacy, offering one possibility of new treatment option as a first-line chemo therapy for patients with HER2-positive advanced gastric cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1) Histologically proven advanced or recurrent adenocarcinoma
- •2) No prior therapy except for adjuvant chemotherapy of S-1 finished more than 6 months before
- •3) With measurable lesions by RECIST version 1.1
- •4) HER2 positive (IHC 3+ or IHC 2 + and ISH +)
- •5) Age 20 - 75
- •6) ECOG PS 0 or 1
- •7) No symptomatic cerebral lesions
- •8) Adequate organ functions
- •9) LVEF (Left Ventricular Ejection Fraction) > 50 %
- •10) No abnormal findings in ECG
- •11) Possible for oral intake
- •12) With an expected survival longer than 3 months
- •13) Wth written Informed consent
排除标准
- •1) Could not administrate S-1, oxaliplatin, and trastuzumab
- •2) Pregnant and/or nursing women or men who wish to have children in future
- •3) With active infectious disease
- •4) HBs antigen positive
- •5) With a history or current symptoms of heart failure, uncontrollable arrhythmia, angina pectoris, valvular disease, and uncontrollable hypertension
- •6) With interstitial pneumonia, pulmonary fibrosis, heart failure, renal failure, hepatic failure, uncontrollable diabetes mellitus
- •7) With dyspnea at rest
- •8) With active bleeding from gastric cancer / ulcer
- •9) With severe diarrhea
- •10) With severe sensory neuropathy
- •11) With active double cancers excluding carcinoma in situ and/or prior curative cancer with relapse free for more than 5 years
- •12) Under meditation of flucytosine, phenytoin,or warfarin
- •13) Under continuous meditation of steroids
- •14) Judged to be unfit to participate in this study by investigator
研究者
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