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To evaluate the efficacy and safety of trifluridine/tipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| research group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate,ORR | Perform imaging evaluation At the end of Cycle 2 or Cycle3 (each cycle is 28 days). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Fu He | Contact | +86 13053069237 | michaelhww@zju.edu.cn |
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|
| ID | Term |
|---|---|
| D014271 | Trifluridine |
| C000613754 | tipiracil |
| C000613803 | trifluridine tipiracil drug combination |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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