NCT07371871尚未招募不适用
A Prospective, Single-arm, Exploratory Study of Trifluridine/Tipiracil (TAS-102) Combined With Apatinib as Third-line Therapy for Advanced Gastric Cancer
Anhui Provincial Cancer Hospital0 个研究点目标入组 30 人开始时间: 2026年1月8日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Objective Response Rate，ORR
研究概览
简要总结
To evaluate the efficacy and safety of trifluridine/tipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric cancer confirmed by histopathological or cytological diagnosis;
- •unresectable locally advanced or recurrent/metastatic gastric cancer;
- •age 18-75 years, regardless of gender;
- •ECOG score 0-2;
- •previously received second-line treatment for advanced gastric cancer with disease progression during or after treatment;
- •at least one measurable lesion present according to RECIST 1.1 criteria;
- •laboratory tests meeting the following requirements: (1) Blood routine: HGB≥70g/L; WBC≥4.0×10^9/L; NEUT≥1.5×10^9/L; PLT≥90×10^9/L; (2) Blood biochemistry: ALT, AST≤2.5×upper limit of normal (ULN), serum creatinine≤1.5×upper limit of normal;
- •negative pregnancy test for patients of childbearing potential and voluntary use of effective and reliable contraception during the trial.
排除标准
- •Participation in other anti-tumor drug clinical trials within 4 weeks prior to enrollment;
- •Any of the following conditions that may interfere with oral medication: inability to swallow, chronic diarrhea, or intestinal obstruction;
- •Concurrent receipt of any other systemic anti-tumor therapy (excluding local treatment);
- •Previous treatment with VEGFR inhibitors (excluding ramucirumab; pan-targeted TKIs are excluded);
- •Known history of allergy to any component of the study drugs;
- •Subjects with active infectious diseases;
- •Patients deemed unsuitable for enrollment by the investigator due to potential increased study-related risks or possible interference with interpretation of study results, as assessed by the investigator.
研究组 & 干预措施
research group
Experimental
干预措施: Trifluridine/Tipiracil (TAS-102) combined with Apatinib (Drug)
结局指标
主要结局
Objective Response Rate，ORR
时间窗: Perform imaging evaluation At the end of Cycle 2 or Cycle3 (each cycle is 28 days).
次要结局
- Duration of Response，DOR(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.)
- Progression-Free Survival，PFS(From date of first dose administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.)
研究者
Wang Xiaojing
Chief Physician.
Anhui Provincial Cancer Hospital
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