JPRN-jRCTs041210105招募中2 期
Phase II study investigating efficacy and safety of trifluridine/tipiracil (FTD/TPI) plus ramucirumab (Ram) as third-line or later treatment for advanced gastric cancer
Kodera Yasuhiro0 个研究点目标入组 32 人开始时间: 2021年11月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically confirmed gastric cancer; one of the general types of histological classification or gastric carcinoma with lymphoid stroma
- •2) Histologically confirmed unresectable, advanced or recurrent gastric cancer (including esophago-gastric junctional cancer)
- •3) Must be refractory or ineligible to at least 2 prior lines of standard of care systemic therapy.
- •4) 20 years and over of age on the day of signing informed consent
- •5) Patients with adequate oral intake
- •6) Performance status (PS) 0-2
- •7) Adequate function of vital organs, including bone marrow, liver, and kidney within 14 days before registration
- •8) Written informed consent
排除标准
- •1) Patients previously received FTD/TPI
- •2) Patients with active double cancer
- •3) Patients with active infectious disease
- •4) Females who are pregnant or breastfeeding or plans of pregnancy, males who wish that his partner to be pregnant
- •5) Patients with grade 3 or higher peripheral neuropathy
- •6) Patients with grade 2 or higher diarrhea
- •7) Patients with serious non-healing wound, ulcer, or bone fracture
- •8) Patients with serious complications
- •9) Patients with psychiatric disease
- •10) Patients with a history of allergy to ramucirumab or severe hypersensitivity to the components contained in the study drug
- •11) Patients with ineligible for the study at the physician's assessment
研究者
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