HER2 positive advanced or unresectable gastric cancer
Conditions
Interventions
Four-drug combination
Nivolumab, S-1 /Capecitabine, Oxaliplatin and Trastuzumab
Sponsors
The Cancer Institute Hospital of JFCR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)HER2 positive advanced or unresectable gastric or GEJ cancer that had been confirmed as histological adenocarcinoma. 2)Never been treated by any chemotherapies including for other cancers, chemoradiotherapies, radiation therapies, or hormone therapies. 3)Have at least one evaluable lesion(based on RECIST ver.1.1) 4) Overexpression of HER 2 (IHC 3+, or IHC 2+ and ISH positive [FISH or DISH method]). 5)Age of 20 years and older 6)ECOG Performance Status (PS) is 0 or 1. 7)Functions of main organs (bone marrow, liver, kidney, brain, and blood) are maintained. 8)Have left ventricular ejection rate (LVEF)50% and over measured by echocardiogram or MUGA scan 9)No clinically significant findings in 12-lead electrocardiogram 10)Adequate oral intake. 11)Expected alive more than 3 months. 12)Written informed consent.
Exclusion criteria
Exclusion criteria: Patients who; 1) have complication or history of severe hypersensitive reactions against any antibody products 2)have any active double cancer with less than 5 years of disease-free interval 3)have any active infection diseases 4)have any of heart diseases or conditions within 6 months before registration; 5)are breastfeeding or not ruled out the potency of pregnancy prior to registration 6)not acknowledge for the birth control minimum 5 months for women and 7months for men after the latest last administration 7)have dyspnea at rest due to lung metastasis or cardiovascular diseases 8)have metastatic lesions in brain or meninges 9)have diarrhea 10)have concomitant of autoimmune diseases, or history of chronic or recurrent autoimmune diseases 11)require the administrations of systemic adrenocortical hormone or immunosuppresses, or had treated by them within 28 days before registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Adverse events, laboratory findings and vital signs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability | — |
Countries
Japan
Contacts
Public ContactDaisuke Takahari
The Cancer Institute Hospital of JFCR Gastroenterology Center Gastroenterology medical oncology
Outcome results
None listed