Primary Objectives
* In phase 1b cohort, to determine MTD (maximum tolerated dose) of nal-IRI (ONIVYDE®) in combination with Ramucirumab (Cyramza®) and TAS-102 (LONSURF®) * In phase II cohort, to evaluate disease objective response rate (ORR) of Ramucirumab (Cyramza®), nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) Secondary Objectives * To evaluate disease control rate (DCR) * To evaluate progression-free survival (PFS) * To evaluate overall survival (OS) * To assess the safety profile * To study the blood biomarkers
histologically or cytologically confirmed metastatic gastric adenocarcinoma
patients have received only first line of systemic therapy, including recurrence during adjuvant therapy or within 6 months after the completion of adjuvant treatment.
ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1
patients with HER2/neu-positive tumor must be exposure to Herceptin treatment
patient can't take oral drugs;
known hypersensitivity to irinotecan, fluoropyrimidine, or ramucirumab;
receipt of surgery within the past 4 weeks before study enrollment;
≥ grade 2 diarrhea and ascites
National Health Research Institutes, Taiwan
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Collaborator
China Medical University Hospital
Collaborator
National Cheng-Kung University Hospital
Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborator
Chang Gung Memorial Hospital
Collaborator