Neoadjuvant toripalimab plus axitinib for clear cell renal cell carcinoma with inferior vena cava tumor thrombus:NEOTAX,a phase 2 study  

作　　者：Liangyou Gu Cheng Peng Qiyang Liang Qingbo Huang Deqiang Lv Houming Zhao Qi Zhang Yu Zhang Peng Zhang Shichao Li Junnan Xu Luyao Chen Yongpeng Xie Jinhang Li Gang Guo Xu Zhang Baojun Wang Xin Ma 

机构地区：[1]Department of Urology,Chinese PLA General Hospital,Beijing,China [2]Chinese PLA Medical School,Beijing,China [3]China National Center for Bioinformation,Beijing,China [4]Beijing Institute of Genomics,Chinese Academy of Sciences,Beijing,China [5]University of Chinese Academy of Sciences,Beijing,China [6]Department of Urology,The First Affiliated Hospital of Nanchang University,Nanchang,China [7]Department of Urology,The First Affiliated Hospital of Chongqing Medical University,Chongqing,China [8]Department of Pathology,Chinese PLA General Hospital,Beijing,China

出　　处：《Signal Transduction and Targeted Therapy》2024年第11期5157-5165,共9页信号转导与靶向治疗（英文）

基　　金：supported by the National Natural Science Foundation of China(Nos.82373169,82273412,82372704).

摘　　要：The potential benefit of neoadjuvant toripalimab plus axitinib in cases with clear cell renal cell carcinoma(ccRCC)and inferior vena cava tumor thrombus(IVC-TT)remains unclear.NEOTAX was a phase 2 study to investigate the efficacy and safety of neoadjuvant toripalimab plus axitinib in patients with ccRCC and IVC-TT(ChiCTR2000030405).The primary endpoint was the down-staging rate of IVC-TT level.Secondary endpoints included change in TT length,response rate,percentage change in surgical approach,surgical morbidity,progression-free survival(PFS),safety,and biomarker analyses.In all,25 patients received study treatment,44.0%(11/25)patients had a reduction in thrombus level,and none experienced an increase in Mayo level.The median change in tumor thrombus length was−2.3 cm(range:−7.1 to 1.1 cm).Overall,61.9%(13/21)patients experienced changes in surgical strategy compared with planned surgery,three patients experienced major complications.The median PFS was 25.3 months(95%CI:17.0-NE).The 1-year PFS was 89.1%(95%CI:62.7-97.2).No any of grade 4 or 5 treatment-related adverse event was identified.Biopsy samples of nonresponders exhibited increased T cytotoxic cell infiltration,but these cells were predominantly PD-1 positive.Biopsy samples of responders exhibited lower T helper cells,however,their subtype,regulatory T cells remained unchanged.In surgical samples of the TT,non-responders exhibited increased CD8T_01_GZMK_CXCR4 subset T cells.NEOTAX met preset endpoints proving that toripalimab in combination with axitinib downstages IVC-TT in a significant proportion of patients leading to simplification in the procedure of surgery.

关 键 词：THROMBUS unchanged PHASE 

分 类 号：R737.11[医药卫生—肿瘤]