Clinical trial · Interventional
A Prospective, Single-arm, Exploratory Study of Trifluridine/Tipiracil (TAS-102) Combined With Apatinib as Third-line Therapy for Advanced Gastric Cancer
NCT07371871CI-TRIAL-00101859not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of trifluridine/tipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trifluridine/Tipiracil (TAS-102) combined with Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- research group
- interventionNames
- Drug: Trifluridine/Tipiracil (TAS-102) combined with Apatinib
Primary outcomes (1)
- measure
- Objective Response Rate,ORR
- timeFrame
- Perform imaging evaluation At the end of Cycle 2 or Cycle3 (each cycle is 28 days).
Secondary outcomes (2)
- measure
- Duration of Response,DOR
- timeFrame
- 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.
- measure
- Progression-Free Survival,PFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.