jRCTs041210105进行中（未招募）不适用
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
未提供0 个研究点目标入组 32 人开始时间: 2022年2月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histologically confirmed gastric cancer; one of the general types of histological classification or gastric carcinoma with lymphoid stroma
- •Histologically confirmed unresectable, advanced or recurrent gastric cancer (including esophago-gastric junctional cancer)
- •Must be refractory or ineligible to at least 2 prior lines of standard of care systemic therapy.
- •20 years and over of age on the day of signing informed consent
- •Patients with adequate oral intake
- •Performance status (PS) 0-2
- •Adequate function of vital organs, including bone marrow, liver, and kidney within 14 days before registration
- •Written informed consent
排除标准
- •Patients previously received FTD/TPI
- •Patients with active double cancer
- •Patients with active infectious disease
- •Females who are pregnant or breastfeeding or plans of pregnancy, males who wish that his partner to be pregnant
- •Patients with grade 3 or higher peripheral neuropathy
- •Patients with grade 2 or higher diarrhea
- •Patients with serious non-healing wound, ulcer, or bone fracture
- •Patients with serious complications
- •Patients with psychiatric disease
- •Patients with a history of allergy to ramucirumab or severe hypersensitivity to the components contained in the study drug
- •Patients with ineligible for the study at the physician's assessment
结局指标
主要结局
-
Time to treatment failure
次要结局
未报告次要终点
研究者
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