Advanced Gastric Cancer
Conditions
Keywords
Advanced Gastric Cancer, TAS-102, Apatinib
Brief summary
To evaluate the efficacy and safety of trifluridine/tipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer
Interventions
DRUGTrifluridine/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.
Sponsors
Anhui Provincial Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate，ORR | Perform imaging evaluation At the end of Cycle 2 or Cycle3 (each cycle is 28 days). |
Secondary
| Measure | 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. |
Contacts
CONTACTYi Fu He
Outcome results
None listed