A Prospective, Single-arm, Exploratory Study of Trifluridine/Tipiracil (TAS-102) Combined With Apatinib as Third-line Therapy for Advanced Gastric Cancer

Inclusion criteria

• 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.

Exclusion criteria

• 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.