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

• Trifluridine/Tipiracil (TAS-102) combined with Apatinib (Drug): TAS-102: 35 mg/m2/dose, taken orally within 1 hour after breakfast and dinner, twice daily, on days 1-5 of each cycle, followed by a 9-day drug-free interval, with 28 days constituting one cycle. Apatinib: 500 mg/dose, once daily, administered continuously for 5 days followed by a 2-day break, with 28 days as one cycle. Imaging evaluation should be performed every 2-3 cycles until disease progression or intolerance occurs.

Primary outcomes

• Objective Response Rate，ORR [Perform imaging evaluation At the end of Cycle 2 or Cycle3 (each cycle is 28 days).]

Secondary outcomes

• 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.]

Sex: All, ages: 18 Years to 75 Years

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.