A phase ll study of TS-1+L-OHP(SOX) therapy for Her2-negative advanced/metastatic gastric cancer with measurable lesions (OGSG1405) - SOX therapy for Her2-negative gastric cancer (OGSG1405)

Osaka Gastrointestinal Cancer Chemotherapy Study Group0 个研究点目标入组 55 人开始时间: 2015年3月31日最近更新: 2023年10月17日

适应症

试验速览

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•1) With history of chemotherapy and/or radiation therapy 2) with active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval 3) with symptoms due to metastasis in the central nerve 4) have a history of severe drug hypersensitivity 5) with below comorbidity; 1. uncontrolled DM 2. uncontrolled hypertension 3. liver cirrhosis, hepatic failure 4. renal failure 5. interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema 6. with active infectious diseases 7. with a history of heart failure, cardiac infarction, angina pectoris and/or abnormal electrocardiogram within 6 months 6) HBs antigen positive 7) with active bleeding 8) with sensory neuropathy 9) with severe diarrhea (over 4 times a day or watery diarrhea ) 10) under medication of flucytosine phenytoin or warfarin 11) under continuous steroids medication 12) women pregnant and/or nursing or men who like to have children in future 13) patients with a psychological disease or symptoms whom physician in charge judges to be unable to participate 14) Any patients judged by the physician in charge to be unfit to participate in the study

发起方

Osaka Gastrointestinal Cancer Chemotherapy Study Group