Phase ll trial of TS-1 + CDDP + Trastuzumab(SPT)-3 weekly schedule in HER2-positive advanced gastric cancer(HERBIS-1) (OGSG 1101) - HER2-Based Strategy in Gastric Cancer(HERBIS-1) (OGSG 1101)

Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)0 个研究点目标入组 56 人开始时间: 2011年6月10日最近更新: 2023年10月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 56

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 56 patients were enrolled. In the full analysis set of 53 patients, the confirmed RR was 68% (95% confidence interval (CI)=54-80%), and the disease control rate was 94% (95% CI=84-99%). Median OS, PFS, and TTF were estimated as 16.0, 7.8, and 5.7 months, respectively.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 75years-old（—）
性别: All

入选标准

未提供

排除标准

•1. Patients who are contraindicated to S-1, CDDP, and Trastuzumab. 2. Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant. 3. Patients with active infection. 4. Patients have Active hepatitis type B. 5.Serious illness or medical conditions as defined below; a. Patient with a previous history of congestive heart failure b. Hi-risk uncontrolled arrhythmias c. Unstable angina requiring medication d. Patient with a previous history of myocardial infarction e. Severe heart valve disease f. Patient with a previous history of transmural infarct g. Uncontrolled hypertension 6. Serious complication as followings ; a. Interstitial pneumonia b. Pulmonary fibrosis c. Heart failure d. Renal failure e. Hepatic failure f. Uncontrolled diabetes mellitus 7. Patients with resting dyspnea 8. Patients with fresh bleeding from gastric cancer and/or the digestive tract 9. Patients with diarrhea (4 or more times per day or watery diarrhea). 10.Second primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence) 11. Patients who are received systemic continuous administration of flucytosine, phenytoin, or warfarin. 12. Patients who are received systemic administration of corticosteroid. 13. Any patients judged by the investigator to be unfit to participate in the study.

研究者

发起方

Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

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