Phase II clinical trial of S-1/L-OHP+Trastuzumab for HER2 positive gastric cancer - Phase II clinical trial of S-1/L-OHP+Trastuzumab for HER2 positive gastric cancer

agoya City University Hospital, Department of gastroenterology0 个研究点目标入组 25 人开始时间: 2015年4月20日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 25

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

A total of 25 patients from six centers were enrolled. In the 25 patients evaluable for analysis, the 1-year survival rate was 70.8% [90% confidence interval (CI) = 55.5-86.1%], whereas the median OS, PFS, and ORR were 17.8 months, 7.6 months, and 75.0%, respectively. Major grade 3/4 adverse events included anorexia (20%), anemia (16%), peripheral sensory neuropathy (16%), and diarrhea (15%). SOX100 combined with trastuzumab was effective with a favorable safety profile in patients with HER2-positive AGC.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 80years-old（—）
性别: All

入选标准

未提供

排除标准

•1.patient who has drug allergy as past history 2. case of administration contraindication 3. patient who needs flucytosine, phenytoin, and Warfarin 4. patient who has active infectious disease with fever over 38 degree 5. patient who has severe complication (intestinal palsy, ileus, interstitial pneumonia, DM, renal failure, liver failure under bad control) 6. patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart) 7. patient who has metastatic brain tumor with symptoms 8. watery diarrhea 9. severe ascites and/or pleural effusion 10. patient who has active double cancer 11. patient who want to be pregnant and /or pregnant woman 12. man who want to have a child 13. patient who was not judged to be suitable for this clinical trial

研究者

发起方

agoya City University Hospital, Department of gastroenterology

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