A Research for an immunotherapy combined with chemotherapy for patients with advanced solid tumors.

10例晚期实体瘤患者完成了临床试验。所有患者均未发生严重不良事件。治疗后4周和7周的临床反应分别显示，病情稳定（SD） 9例和5例，病情进展（PD） 1例和4例。环磷酰胺（CPM）治疗后循环调节性T细胞（Treg）频率显著降低，Treg下降率较高与临床疗效良好有关。SD患者rnf43特异性循环T细胞阳性反应率显著升高。PD患者治疗前血清IL-6和IL-10水平升高。综上所述，免疫治疗联合CPM是可耐受的，可诱导肿瘤特异性免疫反应，同时降低Tregs，对晚期实体瘤有效。IL-6和IL-10被认为是提前预测临床反应的良好生物标志物。

Ten patients with advanced solid tumors were completed with the clinical trial. None of the patients suffered from severe adverse events. Clinical responses at 4 and 7 weeks after the treatment respectively showed that 9 and 5 patients were in stable disease (SD), and 1 and 4 patients were in progress disease (PD). The frequency of circulating regulatory T cells (Treg) significantly decreased after cyclophosphamide (CPM), and the higher decreasing rate of Treg was related with good clinical response. The positive response rate of RNF43-specific circulating T cells significantly increased in SD cases. Higher levels of serum IL-6 and IL-10 prior to the treatment were observed in PD cases. In conclusion, the combination of immunotherapy and CPM was tolerable, and may induce tumor specific immune responses accompanied by the reduction of Tregs and be efficient against advanced solid tumors. Both of IL-6 and IL-10 are considered to be good biomarkers to predict clinical response in advance.