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

NCT07371871 | Not Yet Recruiting

• 1 other identifier: 2025-LLYJ-0022
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Advanced Gastric Cancer

Keywords

Advanced Gastric Cancer; TAS-102; Apatinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate，ORR

  Perform imaging evaluation At the end of Cycle 2 or Cycle3 (each cycle is 28 days).

Secondary Outcomes (2)

• 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.

Study Arms (1)

research group

EXPERIMENTAL

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

Interventions

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.

research group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead

MeSH Terms

Interventions

Trifluridine; tipiracil; trifluridine tipiracil drug combination; apatinib

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Yi Fu He

CONTACT

+86 13053069237; michaelhww@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician.

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 28, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01