A Feasibility Trial of Nivolumab With Neoadjuvant CF or DCF Therapy for Locally Advanced Esophageal Carcinoma

Prior treatment

• Patients who have unstable angina or a medical history of myocardial infarction within 6 months before enrollment
• Patients who have a medical history of treatment with an anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or any other antibody for inhibition or modulation of T cell costimulatory pathway or cancer vaccine."

Other illness

• Patients who have active multiple cancers
• Patients who have an infectious disease that is active and need the systemic treatment
• Positive with HBs antigen, HCV-RNA or anti-HIV antibody, or anti-HTLV-1 antibody tests
• Negative with HBs antigen test and positive with anti HBs antibody or anti HBc antibody tests, and positive with HBV-DNA quantitative test
• Patients who have Psycosis or psychiatric symptoms are judged inappropriate for participation in the trial
• Patients who have a medical history of allergy to iodine
• Patients who have hypersensitivity to docetaxel, cisplatin, and drug-containing polysorbate 80
• Patients who have a complication or a history of highly sensitive reactions to antibody formulations
• Patients who have uncontrollable hypertension
• Patients who have diverticulitis or symptomatic peptic ulcer disease
• Patients who have a history of transplantation therapy, such as hematopoietic stem cell transplantation

Lab values

• Patients who need the treatment with continued use of flucytosine, phenytoin, or warfarin potassium
• Even if insulin or oral hypoglycemic agent is continued use, the result of HbA1c test is 6.5% or more in JDS or 6.9% or more in NGSP

Other

• Pregnant, suspected pregnant, or lactating
• Patients who have advanced pulmonary emphysema, which is observed by pulmonary function test or CT test

• Endoscopic biopsy of esophageal primary lesion histologically diagnosed as squamous cell carcinoma, adenosquamous carcinoma, or basal cell carcinoma
• All esophageal cancer lesions are localized in the thoracic esophagus
• Patients are classified as clinical stage T1N1-3M0 or T2-3N0-3M0 in the UICC-TNM classification 8th edition
• The age is over 20 years old and under 75 on the enrollment date
• PS 0-1
• With or without measurable lesions
• Patients who have no medical history of treatment for esophageal cancer
• Patients who have no medical history of chemotherapy, radiotherapy, and endocrine therapy, including treatment for other types of cancer
• The results of laboratory tests within 14 days before enrollment meet the inclusion criteria
• Esophageal cancer radical surgery (R0) by open-chest surgery (or thoracoscopic surgery) and laparotomy (or laparoscopic surgery) is judged possible
• Patients who have no complication or history of thyroid dysfunction
• Patients who have no complication or history of autoimmune disease
• Patients who don't have treatment with systemic corticosteroids (dose of 10mg/day over in prednisolone equivalent) or immunosuppressants within 14 days before enrollment
• Patients who have no complication or history of pneumonitis or pulmonary fibrosis which had been diagnosed by imaging tests or physical examination
• For females, who have agreed with contraception from start of investigational drug administration to 5 months after last dose of an investigational drug. For males who have agreed with contraception from start of investigational drug administration to 7 months after last dose of an investigational drug.
• Obtained written informed consent from patients"