Gastric Cancer Gastric Cancer
Conditions
Interventions
CapeOX and nivolumab are administered every 3 weeks at the following dose
capecitabine: 1000 mg/m2 two times per day on day 1-14
oxaliplatin: 130 mg/m2 on day 1
nivolumab: 360 mg on day 1
Not applicable
Sponsors
Fujii Masashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tumular adenocarcinoma, poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma, or carcinoma with lymphoid stroma of stomach or esophagogastric junction 2) Radiologically diagnosed recurrence during or 18 years 4) ECOG performance status of 0-1 5) HER2 negative 6) Presence of measurable lesions according to RECIST ver.1.1 7) Adequate oral intake 8) Adequate organ functions
Exclusion criteria
Exclusion criteria: 1) Prior treatment with immune checkpoint inhibitors 2) Refractory to pre-operative chemotherapy or chemoradiotherapy including platinum compounds 3) Multiple cancers 4) Active autoimmune diseases 5) Grade > 2 peripheral sensory and/or motor neuropathy 6) Symptomatic brain metastasis 7) Interstitial pneumonia or pulmonary fibrosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression-free survival, Disease control rate, Duration of response, Safety | — |
Contacts
Public ContactHiroyuki Arai
St. Marianna University Hospital
Outcome results
None listed