JPRN-jRCT2061180016
进行中（未招募）
2 期
Preoperative Nivolumab (Opdivo) to evaluate pathologic response in patients with stage I non-small cell lung cancer: a phase 2 trial - POTENTIA
Okada Morihito0 个研究点目标入组 50 人2019年1月29日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Okada Morihito
- 入组人数
- 50
- 状态
- 进行中（未招募）
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\) Histologically or cytologically confirmed Non Small Cell Lung Cancer
- •2\) Resectable NSCLC patients with clinical stage I (by UICC\-TNM ver. 8\), defined as having a high risk of reccurrence (pure solid or solid tumor size:2\-4cm)
- •3\) ECOG PS 0\-1
- •4\) Have a measurable target lesion, designated by RECIST ver.1\.1
- •5\) Patients with no serious disease which make the surgery to be impossible to do
- •6\) Patient who is considered capable of lobectomy
- •7\) Age: More than 20 years old
- •8\) Meet the defined criteria of the results of laboratory tests on screening visit
- •9\) For Women of Childbearing Potential (WOCBP), the result of pregnancy test (14 or less days before enrollment) is negative
- •10\) WOCBP who has agreed with contraception until 5 months after last administration of nivolumab
排除标准
- •1\) Positive for EGFR mutation (deletion of exon 19, or point mutation on exon21, L858R), ALK translocation or ROS 1 translocation tests
- •2\) Known or suspected autoimmune disease
- •3\) Patients requiring treatment with systemic corticosteroids (over 10 mg/day dose) or immunosuppressants within 14 days before enrollment
- •4\) Receive or plan to receive live or attenuated vaccine within 28 days prior to registration
- •5\) Patients who have obvious interstitial lung disease or pulmonary fibrosis by chest CT test
- •6\) Patients with concomitant or a history of tuberculosis
- •7\) Patients who have serious or uncotrollable disease
- •8\) Patients who have prior therapy with chemotherapy or any other anti\-cancer therapy for early stage of NSCLC
- •9\) Patients who have medical history of treatment with anti PD\-1 antibody, anti PD\-L1/L2 antibody, anti CTLA\-4 antibody or any other antibody for inhibition or modulation of T cell costimulatory pathway
- •10\) Positive for HBs antigen, HCV antibody, HIV antibody or HTLV\-1 antibody tests
结局指标
主要结局
未指定
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