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 Hospital

Status

Not yet enrolling

Conditions

Advanced Gastric Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

2025-LLYJ-0022

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.