Not yet recruiting NCT07371871

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

No phase Interventional Advanced Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Trifluridine/Tipiracil (TAS-102) combined with Apatinib.
Who it may be relevant to: Registry conditions: Advanced Gastric Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

To evaluate the efficacy and safety of trifluridine/tipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer

Drug Trifluridine/Tipiracil (TAS-102) combined with Apatinib
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.

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

Secondary outcome measures (2)

Duration of Response，DOR [Time frame: 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 [Time frame: 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.]

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Center list to be confirmed — check the primary protocol.

NCT: NCT07371871 · 2025-LLYJ-0022