Department of Frontier Science for Cancer and Chemotherapy, Osaka University, Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Jpn J Clin Oncol. 2013 Aug;43(8):838-40. doi: 10.1093/jjco/hyt083. Epub 2013 Jul 12.
Irinotecan is a key drug in second- or further-line chemotherapy for patients with advanced gastric cancer. Continuous administration of trastuzumab beyond first progression is expected to contribute to the benefit of chemotherapy for human epidermal growth factor receptor 2-positive gastric cancer. The aim of this trial is to evaluate the efficacy and safety of combination chemotherapy with trastuzumab and irinotecan in Japanese patients with advanced human epidermal growth factor receptor 2-positive chemo-refractory gastric cancer. The primary endpoint is the disease control rate. The secondary endpoints are adverse events, overall response rate, time to treatment failure, progression-free survival, overall survival and response rate stratified by prior trastuzumab use. A total of 30 patients will be enrolled in this Osaka Gastrointestinal Cancer Chemotherapy Study Group trial.
伊立替康是晚期胃癌二线或后线化疗的关键药物。曲妥珠单抗在首次进展后继续给药有望为人表皮生长因子受体 2 阳性胃癌的化疗带来获益。本试验旨在评估曲妥珠单抗联合伊立替康在日本晚期人表皮生长因子受体 2 阳性化疗耐药性胃癌患者中的疗效和安全性。主要终点为疾病控制率。次要终点为不良事件、总缓解率、治疗失败时间、无进展生存期、总生存期和根据既往曲妥珠单抗使用情况分层的缓解率。本研究由大阪胃肠癌化疗研究组开展，共入组 30 例患者。
