TCTR20220328005招募中2 期
Phase II single-arm study of Trastuzumab combination with Cisplatin and Gemcitabine as first-line therapy in the HER-2 positive Advanced CholangioCArcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Age 18-70 years
- •2. Radiographic evidence of advanced cholangiocarcinoma or gallbladder cancer not amenable for curative treatment
- •3. Histology-confirmed diagnosis
- •4. HER-2 IHC 2-3+ AND FISH positive
- •5. No previous systemic therapy except last adjuvant chemotherapy at least 6 months
- •6. ECOG performance 0-1
- •7. Measurable lesion
- •7. Adequate organ function e.g. CrCl at least 50 mL/min, LVEF at least 50%
排除标准
- •1. Ampullary cancer
- •2. Mixed histology e.g. HCC, SCC, NET, small cell carcinoma
- •3. HER2 activating mutation without HER-2 amplification
研究者
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