Addition of Dendritic Cell Vaccination to Conditioning Cyclophosphamide and Chemoembolization in Patients with Hepatocellular Carcinoma: The ImmunoTACE Trial.

The ImmunoTACE trial evaluated the preliminary activity of this vaccine in combination with transarterial chemoembolization (TACE) in patients with intermediate-stage hepatocellular carcinoma.

ImmunoTACE试验评估了这种疫苗与经动脉化疗栓塞(TACE)联合使用在中期肝细胞癌患者中的初步活性。

patients_and_methods

A randomized phase II trial was conducted in three tertiary referral centers in the United Kingdom.

在英国的三个三级转诊中心进行了一项随机II期试验。

Eligible patients were randomly assigned in a 1:1 ratio to TACE + preconditioning cyclophosphamide or to TACE + preconditioning cyclophosphamide + DC infusions.

符合条件的患者按照1:1的比例随机分配接受TACE+预处理环磷酰胺治疗或TACE+预处理环磷酰胺+DC输注治疗。

The primary endpoint was progression-free survivaltime using RECIST v1.1 criteria.

主要终点是使用RECIST v1.1标准的无进展生存时间。

Additional endpoints included safety and immune responses.

次要终点包括安全性评估和免疫反应。

Results

Between March 2016 and October 2019, 55 patients were randomized, of whom 48 were evaluable (24 in each group).

2016年3月至2019年10月期间，共有55名患者被随机分配，其中48名患者可进行评估（每组24名）。

The median progression-free survivaltime using RECIST criteria was 18.6 months in patients treated with chemoembolization + preconditioning cyclophosphamide + DC infusions compared with 10.4 months in those treated with chemoembolization + preconditioning cyclophosphamide alone (HR = 0.43; upper value of one-sided 80% confidence interval, 0.57; P = 0.016).

使用RECIST标准评估，接受化疗栓塞+预处理环磷酰胺+树突状细胞输注治疗的患者中位无进展生存期为18.6个月，而仅接受化疗栓塞+预处理环磷酰胺治疗的患者为10.4个月（风险比HR=0.43；单侧80%置信区间的上限值为0.57；P=0.016）。

The addition of DC infusions did not significantly increase the incidenceor severity of adverse events.

树突状细胞（DC）输注的加入并未显著增加不良事件的发生率或严重程度。

An enhanced antigen (α-fetoprotein)-specific immune response was observed in patients treated with DC vaccination.

在接受树突状细胞（DC）疫苗治疗的患者中，观察到针对抗原（甲胎蛋白）的特异性免疫反应增强。

Conclusions

The addition of DC infusions to TACE and preconditioning cyclophosphamide has shown promising preliminary activity and merits further investigation in a larger randomized trial.

将树突状细胞输注添加至经动脉化疗栓塞(TACE)和预处理环磷酰胺中，显示出有希望的初步疗效，并且值得在更大规模的随机试验中进行进一步研究。