ivOlumaB and chemoradiotherapy for EsophageaL cancer
- Conditions
- Esophageal cancer
- Registration Number
- JPRN-UMIN000035889
- Lead Sponsor
- Kyoto university hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 60
Not provided
1. Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers. 2. Current or past history of severe hypersensitivity to any other antibody products. 3. Active autoimmune disease. 4. Intestinal lung disease or pulmonary fibrosis 5. Diverticulitis or peptic ulcer 6. Pleural effusion or ascites necessary for emission 7. Uncontrollable tumor pain 8. Transient ischemic attack, cerebrovascular accident, thrombosis or thromboembolism within 180 days 9. Uncontrollable severe cardiovascular disease 10. Cannot biopsy using the esophagogastoroduodenoscope due to anticoagulant therapy 11. Patients requiring systemic steroid medication or the other immunosuppressive drug excluding corticosteroid drugs before 14 days. 12. Uncontrollable diabetes 13. Treating systemic infection 14. Patients received live vaccines 15. HBs antigen positive or HCV antibody positive 16. Either HBs antibody positive or HBc antibody positive and HBV-DNA detection although HBs antigen is negative 17. Females who are or may be pregnant or lactating 18. Administration of unapproved drugs within 28 days 19. Patients who are incapable of gibing consent (for example, dementia) 20. Any other inadequacy for this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to explored the biomarker for patients treated with chemoradiotherapy + nivolumab
- Secondary Outcome Measures
Name Time Method