Advanced or recurrent esophageal squamous cell carcinoma after cancer chemotherapy
Conditions
Interventions
None listed
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age > 20 years 2) ECOG performance status: 0, 1, or 2 3) Histological diagnosis of primary esophageal squamous cell carcinoma 4) Received at least one regimen of chemotherapy and scheduled to receive nivolumab. 5) Diagnosed with advanced or recurrent unresectable esophageal cancer after cancer chemotherapy at the time of enrollment. 6) Patients with evaluable lesions (whether or not lesions are measurable is irrelevant) 7) Informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between metabolite expression level and therapeutic effects of nivolumab | — |
Countries
Japan
Contacts
Public ContactKenro Hirata
Keio University Hospital Cancer Center
Outcome results
None listed