Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer: A Multicenter, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Loco-regional and Distant Tumor Control After Completion of Treatment
研究概览
简要总结
Trastuzumab plus chemotherapy prolonged the median overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). Among chemotherapy regimens, oxaliplatin is generally more convenient and tolerable than cisplatin, and becoming an increasingly popular option for the treatment of AGC. The aim of the study was to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin (CAPOX) in HER2-positive AGC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HER2-positive AGC defined as either HER2 immunohistochemistry (IHC) 3+ or IHC 2+ and fluorescence in situ hybridization (FISH)+ with no history of previous treatment.
排除标准
- 未提供
研究组 & 干预措施
Tras-Capox
干预措施: Trastuzumab (Drug)
Tras-Capox
干预措施: Oxaliplatin (Drug)
Tras-Capox
干预措施: Capecitabine (Drug)
结局指标
主要结局
Loco-regional and Distant Tumor Control After Completion of Treatment
时间窗: 12 months
Response Evaluation Criteria in Solid Tumors was used to measure outcome: Complete response (CR): Disappearance of all target lesions. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
次要结局
- Progression-free survival (PFS)(28 months)
- Overall survival (OS)(28 months)
研究者
Dr. Ishtiaq-Ur-Rahim
Principal Investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh