NCT04077255招募中2 期
Anti-EGFR Antibody (GC-1118) in Combination With Weekly Paclitaxel as a Second-line Therapy for Gastric and Gastroesophageal Junction Adenocarcinomas With Amplifications
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Based on targeted NGS panel results, metastatic gastric cancer patients with gene amplifications will receive either anti-EGFR antibody (GC-1118) in combination with weekly paclitaxel as a second-line therapy.
详细描述
Participants will receive each treatment if the gastric cancer tissue sample reveals either EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
anti-EGFR
Experimental
Participants will receive GC-1118 in combination with weekly paclitaxel.
干预措施: Anti-EGFR antibody in combination with weekly paclitaxel (Drug)
结局指标
主要结局
Response rate
时间窗: Response rate will be assessed at 8 weeks.
Response rate will be assessed using CT/MRI according to RECIST v1.1.
次要结局
- Progression-free survival(From date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed up to 1 year.)
研究者
Hark Kyun Kim
Principal Investigator
National Cancer Center, Korea
研究点 (1)
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