Esophageal cancer
Conditions
Interventions
mFOLFOX6 and nivolumab are administered every 2 weeks
Nivolumab: 240mg/body
Fluorouracil(bolus): 400 mg/m2
Fluorouracil(continuous): 2400 mg/m2
Oxaliplatin: 85 mg/m2
Levofolinate: 200 mg/m2
Sponsors
Minami Hironobu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically comfirmed squamous cell carcinoma, adenosquamous carcinoma or basaloid carcinoma 2. Untreated unresectable advanced or recurrent esophageal cancer History of prior perioperative or definitive chemotherapy/radiotherapy/chemoradiotherapy is acceptable if completed prior to enrollment, but a recurrence-free period of 24 weeks after completion of treatment is required. 3. Definitive approaches such as chemoradiotherapy or surgery are not feasible 4. Age 18 years or older 5. Men and women 6. ECOG PS 0-2 7. At least one measurable lesion according to RECIST Ver.1.1 8. Latest laboratory values within 14 days prior to enrollment meet all of the following criteria Neutrophil count more than 1500 /mm3 Hemoglobin more than 9.0 g/dL Platelet count more than 100,000 /mm3 Total bilirubin less than 2.0 mg/dL AST/ALT less than 100 U/L (less than 200 U/L in case of liver metastasis) eGFR more than 20 mL/min/1.73m2 9. Any of the following PS 2 75 years old or older eGFR less than 60 mL/min/1.73m2 EF less than 50% Diagnosis with heart failure or ischemic heart disease Poorly controlled arrhythmia Hearing loss Grade 2 or greater 10. Written consent is obtained
Exclusion criteria
Exclusion criteria: 1. Patient with multiple cancers 2. Active systemic infection 3. Patient with active autoimmune disease 4. Systemic corticosteroids (prednisone equivalent greater than 10 mg/day) or other immunosuppressive agents 5. History of or presence of interstitial lung disease 6. Massive ascites or pleural effusion. 7. Unwilling contraceptive patients and pregnant and lactating women. 8. Patients with Grade 2 or higher peripheral neuropathy 9. History of hypersensitivity for the ingredients of this drug 10. Patients of judged to be inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate Progression Free Survival Overall Survival Durable of Response Adverse Event | — |
Contacts
Public ContactYoshiaki Nagatani
Kobe University Hospital
Outcome results
None listed