A Prospective Observational Study in Nivolumab Therapy for Advanced or Recurrent Esophageal Squamous Cell Carcinoma after Cancer Chemotherapy
- Conditions
- Advanced or recurrent esophageal squamous cell carcinoma after cancer chemotherapy
- Registration Number
- JPRN-UMIN000043703
- Lead Sponsor
- Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 200
Not provided
1) Active multiple cancer (synchronous multiple cancer or metachronous multiple cancer where patient has been disease-free for less than 3 years) 2) Prior therapy with anti-PD-1 antibodies (e.g., nivolumab, pembrolizumab), anti-PD-L1 antibodies (e.g., Avelumab, Atezolizumab), anti-CTLA-4 antibodies (e.g., Ipilimumab), or other drugs for T-cell regulation. 3) Receipt of systemic corticosteroids (except for temporary use for testing or prophylactic administration) in excess of 10 mg/day of prednisolone equivalent or or immunosuppressive agents within 14 days prior to enrollment. 4) Patients who have received antibiotics within 14 days prior to registration (Topical medications are acceptable). 5) Patients with the following complications or history of complications a) Complications or history of interstitial lung disease b) Obvious interstitial shadows on chest imaging c) Inflammatory changes due to active radiation pneumonia or infectious pneumonia on chest imaging. d) History of autoimmune disease, or chronic or recurrent autoimmune disease e) History of organ transplantation (including hematopoietic stem cell transplantation). f) Active or history of tuberculosis. 6) Patients deemed unsuitable as study subjects by an investigator for any other reason
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between metabolite expression level and therapeutic effects of nivolumab
- Secondary Outcome Measures
Name Time Method