Background
Methods/design
Objectives
Study design
Inclusion criteria | Exclusion criteria |
---|---|
1) Age of 20 years or above 2) ECOG PS of 0 or 1 3) Histologically diagnosed as gastric adenocarcinoma or EGJ 4) Unresectable progression or recurrence confirmed by CT scan 5) Prior use of fluoropyrimidine, taxanes or irinotecan (patients are eligible even if they have used both drugs), ramucirumab (eligible only for refractory cases) 6) One or more measurable lesions by RECIST version 1.1 7) HER2 test has been performed before registration 8)) Expected to survive for 3 months or more 9) Adequate organ and bone marrow function 10) Written consent has been obtained | 1) Active double cancer (simultaneous double cancer / multiple cancer and metachronous double cancer or multiple cancer with a disease-free period of 2 years or less) 2) Difficulty with oral intake. Specifically, cases that require daily infusion for purposes of nutrition and water intake 3) Pre-treatment including FTD/TPI in the past 4) Hypersensitivity to the drugs used in this study 5) Past history of major surgery (general anaesthesia required) within 4 weeks and/or radiation therapy covering the abdomen within 2 weeks before registration 6) Cases with severe pleural effusion 7) Cases with severe ascites or a history of palliative ascites puncture within 2 weeks before registration 8) Cases with brain metastasis and tumor metastasis to the central nervous system 9) Adverse events (non-haematological toxicity) of poorly controlled Grade 2 or higher (CTCAE v5.0) remain at the time of registration (patients with hair loss, dysgeusia, pigmentation, or peripheral neuropathy may still be registered even if Grade 2 or higher) 10) Local or systemic active infection that requires treatment 11) Uncontrolled hypertension or diabetes mellitus despite adequate treatment 12) Unstable angina within 4 weeks prior to enrolment, uncontrolled heart failure, arrhythmia requiring treatment; excluding arrhythmias that are not clinically problematic 14) Serious haemorrhagic disorders or vasculitis. Cases with significant gastrointestinal bleeding episodes (Grade 3 or higher) within 12 weeks prior to enrolment 15) Past history of gastrointestinal perforation or fistula within 24 weeks prior to registration. Past history of gastrointestinal obstruction or inflammatory bowel disease such as Crohn's disease. However, regarding gastrointestinal obstruction, cases in which colostomy or bypass surgery has been performed in the past and oral intake is sufficiently possible are included 16) Past history of unrecovered trauma, active gastric ulcer, or fracture within 4 weeks prior to enrolment 17) Past history of arterial thrombosis (including myocardial infarction and cerebral infarction) within 24 weeks before registration 18) History of deep vein thrombosis or pulmonary artery thrombosis (excluding catheter thrombosis and superficial thrombosis) within 12 weeks before registration. However, anticoagulation for the prevention of thrombosis is allowed if coagulation function has been stable for at least 12 weeks prior to enrolment (PT-INR ≤ institutional maximum × 1.5) 19) Immune deficiency (such as HIV infection), autoimmune diseases with administration of systemic steroids 20) Patients taking antiplatelet drugs. Low doses of aspirin (less than 325 mg/day) and non-steroidal anti-inflammatory drugs (NSAIDs) are permitted 21) Continuous use of systemic steroids (excluding contrast agent allergy prophylaxis, pre-medication of anti-cancer agents, hydrocortisone replacement therapy for adrenal hypofunction of immune-related adverse events) and immunosuppressive agents 23) HBs-Ag is positive. However, patients can still be registered if HBV infection is controlled by a nucleic acid analogue preparation and no presence of HBV-DNA is confirmed 24) Pregnant women, lactating women, women who may be pregnant or who are not willing to use contraception 25) Difficulty enrolling in this study due to a clinical problem involving mental illness |