Analysis of intratumoral immune response early on Nivolumab treatment in unresectable advanced or recurrent gastric cancer.
- Conditions
- nresectable advanced or recurrent gastric cancer
- Registration Number
- JPRN-UMIN000029622
- Lead Sponsor
- The University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 19
Not provided
1.Synchronous or metachronous (within 5 years) double cancers, except for intoramucosal tumor curatively resected by local therapy 2.Active infection requiring systemic therapy. 3.Active autoimmune diseases or with a history of chronic or repetitive autoimmune diseases. 4.With a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis. 5.Active diverticulitis or inflammatory bowel disease. 6.Poorly controlled diabetes mellitus or thyroid diseases. 7.Unstable angina within 3 weeks or with a history of acute myocardial infarction within 3months. 8.Severe psychological illness. 9.Pregnant or lactating women or women of childbearing potential. 10.Within 4 weeks after live vaccination or 2 weeks after inactiviated vaccination. 11.Judged to be unfit to participate in this study by investigater.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Durable clinical benefit rate, DCBR (DCR more than 4 months)
- Secondary Outcome Measures
Name Time Method Immunological responses Response rate, RR Disease control rate, DCR Progression free survival, PFS Overall survival, OS Adverse events, AE Quality of life, QO