Esophageal cancer patients who can receive the definitive chemoradiotherapy
Conditions
Interventions
Intervention type:DRUG
Name of intervention:Nivolumab
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:INTRAVENOUS DRIP
Dose per administration:
Sponsors
Manabu Muto
National Cancer Center Hospital, National Cancer Center Hospital East, Chiba Cancer Center, Kitasato University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent. 2.Aged 20 to 75 years old. 3.Histologically proven squamous cell carcinoma, adenosquamous cell carcinoma, or basaloid cell carcinoma. 4.Primary lesions are located within the thoracic esophagus. 5.To determine before registration that definitive chemoradiotherapy can be completed safety. Patients with resectable esophageal cancer (T1N1-3M0 or T2-3N0-3M0) do not have a preference to receive a surgical resection as an initial therapy including preoperative chemotherapy. 6.No fistula (esophago-airway, esophago-mediastinal), bleeding due to artery invasion, and respiratory stenosis. Bleeding and fistula are less likely to occur during treatment. 7.No previous treatment except EMR/ESD for esophageal cancer. 8.Measurable lesions not required. 9.Neither radiotherapy, chemotherapy, nor hormone therapy against any cancers except for therapy for any cancer with more than 5 years of disease-free interval. 10.To determine before registration that definitive chemoradiotherapy can be completed safety. 11.ECOG Permormance status 0 or 1. 12.Patients must agree to biopsy when before and after starting CRT for biomarker study. 13.Adequate organ functions. 14.Women of child-bearing potential and men who are able to father a child agree with using adequate contraception. Women must not be breast feeding.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, progression-free survival, complete response rate, time to esophagectomy-free survival | — |
Countries
Japan
Contacts
Public ContactMotoo Nomura
Kyoto University Hospital
Outcome results
None listed