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

January 19, 2026 updated by: Wang Xiaojing, Anhui Provincial Cancer Hospital
To evaluate the efficacy and safety of trifluridine/tipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: research group
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 8, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-LLYJ-0022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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