A phase III study of ONO-4538 (ONO-4538-38/BMS CA209844)
Phase 3
Completed
- Conditions
- Gastric cancer
- Registration Number
- JPRN-jRCT2080223213
- Lead Sponsor
- ONO PHARMACEUTICAL CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 700
Inclusion Criteria
1. With histologically confirmed adenocarcinoma of the stomach
2. Without remnant cancer who have undergone gastrectomy by laparotomy
Exclusion Criteria
1. Have multiple primary cancers
2. Have a current or past history of severe hypersensitivity to any other antibody products
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>relapse-free survival (RFS)
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Overall survival (OS), 3- and 5-year OS rate, 3- and 5-year RFS rate