gastric cancer Gastric cancer
Conditions
Interventions
Patients receive trifluridine/tipiracil (35 mg/m2) orally twice daily on days 1-5 and days 8-12 of each 28 day treatment cycle, plus intravenous ramucirumab (8 mg/kg) on days 1 and 15, followed until
Chemotherapy
Sponsors
Kanda Mitsuro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed gastric cancer; one of the general types of histological classification or gastric carcinoma with lymphoid stroma 2) Histologically confirmed unresectable, advanced or recurrent gastric cancer (including esophago-gastric junctional cancer) 3) Must be refractory or ineligible to at least 2 prior lines of standard of care systemic therapy. 4) 20 years and over of age on the day of signing informed consent 5) Patients with adequate oral intake 6) Performance status (PS) 0-2 7) Adequate function of vital organs, including bone marrow, liver, and kidney within 14 days before registration 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients previously received FTD/TPI 2) Patients with active double cancer 3) Patients with active infectious disease 4) Females who are pregnant or breastfeeding or plans of pregnancy, males who wish that his partner to be pregnant 5) Patients with grade 3 or higher peripheral neuropathy 6) Patients with grade 2 or higher diarrhea 7) Patients with serious non-healing wound, ulcer, or bone fracture 8) Patients with serious complications 9) Patients with psychiatric disease 10) Patients with a history of allergy to ramucirumab or severe hypersensitivity to the components contained in the study drug 11) Patients with ineligible for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to treatment failure | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate, overall survival time, disease-free survival time, response rate, disease control rate, relative dose intensity | — |
Contacts
Public ContactKoki Nakanishi
Nagoya University Hospital
Outcome results
None listed