ivolumab and chemoradiotherapy for esophageal cancer - NOBEL trial

Manabu Muto0 个研究点目标入组 60 人开始时间: 2019年1月29日最近更新: 2023年10月17日

试验速览

暂无简介。

•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.

•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

发起方

Manabu Muto