Prospective study for the usefulness of single nucleotide polymorphism of immune related genes as a predictive factor of nivolumab effect for the patients with advanced non-small cell lung cancer - Prospective study of the nivolumab effect with respect to single nucleotide polymorphism of immune related genes

Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University0 个研究点目标入组 112 人开始时间: 2018年7月17日最近更新: 2023年10月17日

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•1) Chemotherapy was used in the past 21 days. Exceptionally administration of tyrosine kinase inhibitors are not to be excluded. 2)Patients with symptomatic brain metastases and meningeal metastases. However, clinically stable brain metastasis cases can be registered. 3) Uncontrolled pleural effusion, pericardial effusion, and/or ascites. 4) Uncontrolled hyperkalemia. 5) Active double cancer within 5years of the first day of nivolumab treatment. 6) Pregnant or breast-feeding female patients. 7) Autoimmune disease. 8) Evident pulmonary fibrosis, organized pneumonia, drug-induced pneumonia or interstitial lung disease. Patients with active pneumonia at screening CT. 9) Serum albumin < 2.5g/dl 10) Patients with active infectious disease (HBV hepatitis, tuberculosis, pneumonia, sepsis etc.) 11) Ptients with serious heart disease. 12) Attenuated live vaccine within 4 weeks of the first dose of nivolumab, or suppose to be needed during the treatment. 13) Immunostimulant (INF, IL-2, etc) within 6 weeks. 14) Immunosuppressant (predonisoron, cyclophosphamide, azathioprine, methotrexate, etc) within 2 weeks.

发起方

Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University