A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer
- Conditions
- HER2 positive advanced or unresectable gastric cancer
- Registration Number
- JPRN-UMIN000034222
- Lead Sponsor
- The Cancer Institute Hospital of JFCR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 45
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (Adverse events, laboratory findings and vital signs)
- Secondary Outcome Measures
Name Time Method Tolerability