Study design
arrhythmia, multiple cancer, inflammatory bowel disease, diabetes mellitus, autoimmune diseases, Hypersensitivity, Unstable angina, allergy, non-haematological toxicity, arrhythmias, gastrointestinal obstruction, thrombosis, ascites, mental illness, pulmonary artery thrombosis, HBV infection, cancer, vasculitis, gastrointestinal bleeding, fracture, hair loss, dysgeusia, cancer / multiple cancer, unrecovered trauma, adrenal hypofunction, infection, gastric adenocarcinoma, myocardial infarction, gastrointestinal perforation, fistula, active gastric ulcer, peripheral neuropathy
PLEURAL EFFUSION, RECURRENCE, ARRHYTHMIA, MULTIPLE CANCER, INFLAMMATORY BOWEL DISEASE, DIABETES MELLITUS, AUTOIMMUNE DISEASES, HYPERSENSITIVITY, UNSTABLE ANGINA, ALLERGY, WEST, ONCOLOGY, ARRHYTHMIAS, GASTROINTESTINAL OBSTRUCTION, CEREBRAL INFARCTION, THROMBOSIS, ASCITES, DEEP VEIN THROMBOSIS, CANCER, ADVERSE EVENT, VASCULITIS, GASTROINTESTINAL BLEEDING, HAIR LOSS, ADVERSE EVENTS, HIV INFECTION, ADRENAL HYPOFUNCTION, INFECTION, PULMONARY ARTERY THROMBOSIS, TUMOR METASTASIS, CROHN'S DISEASE, HEART FAILURE, GASTRIC ADENOCARCINOMA, BRAIN METASTASIS, UNCONTROLLED HYPERTENSION, MYOCARDIAL INFARCTION, IMMUNE DEFICIENCY, GASTROINTESTINAL PERFORATION, PERIPHERAL NEUROPATHY, ARTERIAL THROMBOSIS
This is a prospective, open-label, randomised, multicentre phase II study, conducted in 47 centres of the West Japan Oncology Group (WJOG) in Japan (Fig. Study schema of RETRIEVE studyKey eligibility criteria for the RETRIEVE study1) Age of 20 years or above2) ECOG PS of 0 or 13) Histologically diagnosed as gastric adenocarcinoma or EGJ4) Unresectable progression or recurrence confirmed by CT scan5) 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 1.17) HER2 test has been performed before registration8)) Expected to survive for 3 months or more9) Adequate organ and bone marrow function10) Written consent has been obtained1) 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 intake3) Pre-treatment including FTD/TPI in the past4) Hypersensitivity to the drugs used in this study5) Past history of major surgery (general anaesthesia required) within 4 weeks and/or radiation therapy covering the abdomen within 2 weeks before registration6) Cases with severe pleural effusion7) Cases with severe ascites or a history of palliative ascites puncture within 2 weeks before registration8) Cases with brain metastasis and tumor metastasis to the central nervous system9) 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 treatment11) Uncontrolled hypertension or diabetes mellitus despite adequate treatment12) Unstable angina within 4 weeks prior to enrolment, uncontrolled heart failure, arrhythmia requiring treatment; excluding arrhythmias that are not clinically problematic14) Serious haemorrhagic disorders or vasculitis. Cases with significant gastrointestinal bleeding episodes (Grade 3 or higher) within 12 weeks prior to enrolment15) 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 included16) Past history of unrecovered trauma, active gastric ulcer, or fracture within 4 weeks prior to enrolment17) Past history of arterial thrombosis (including myocardial infarction and cerebral infarction) within 24 weeks before registration18) 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 steroids20) Patients taking antiplatelet drugs. Low doses of aspirin (less than 325 mg/day) and non-steroidal anti-inflammatory drugs (NSAIDs) are permitted21) 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 agents23) 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 confirmed24) Pregnant women, lactating women, women who may be pregnant or who are not willing to use contraception25) Difficulty enrolling in this study due to a clinical problem involving mental illness