Phase II study of FTD/TPI plus RAM compared with FTD/TPI for advanced gastric cancer (WJOG15822G)

INTERVENTION: Standard of care group (Group A) FTD / TPI monotherapy FTD/TPI (35mg/m2) is orally administered twice daily for 5 days, followed by a 2 days rest period. After repeating this twice, the drug is withdrawn for 14 days. The above is one course and is repeated every 4 weeks until the protocol discontinuation criteria are met. Study treatment group (Group B) FTD/TPI plus Ramucirumab (RAM) FTD/TPI (35mg/m2) is orally administered twice daily for 5 days, followed by a 2 days rest period. After repeating this twice, the drug is withdrawn for 14 days. RAM (8 mg/kg) is administered on day 1 and day 15. The above is one course and is repeated every 4 weeks until the protocol discontinuation criteria are met. CONDITION: gastric cancer, esophagogastric junction adenocarcinoma PRIMARY OUTCOME: Progression‐free survival SECONDARY OUTCOME: Overall survival, Response rate, Disease control rate, Rate of adverse events INCLUSION CRITERIA: 1. Age is 20 years or older. 2. Histologically diagnosed as adenocarcinoma (general type) of the gastric or esophagogastric junction. 3. HER2 test has been performed before registration (regardless of HER status). 4. Unresectable progression or recurrence comfirmed by CT scan. 5. ECOG performance status (PS) is 0 or 1. 6. Expected to survive for 3 months or more. 7. One or more measurable lesions. 8. Pretreatment (refractory or intolerant to the following drugs). Fluoropyrimidine, Taxane or Irinotecan (Eligible even if you have used both drugs), Ramucirumab (eligible only for refractory cases) 9. Organ and bone marrow functions are maintained. 10. Written consent has been obtained.