目的 比较肝动脉灌注化疗(TAI)联合索拉非尼和单用索拉非尼对伴门脉主干或主分支癌栓的肝细胞癌的疗效.方法 前瞻性入组73例首诊为肝细胞癌的患者,随机分为TAI+索拉非尼组( n＝36)和索拉非尼组(n＝37).索拉非尼组患者口服索拉非尼2 次/d,400 mg/次,TAI+索拉非尼组除每天口服索拉非尼外,还进行每3周1次的TAI治疗,采用FOLFOX方案.主要终点是总生存期,次要终点是肿瘤反应、无进展生存期和不良反应.结果 对于中位生存期,TAI+索拉非尼组明显优于索拉非尼组(10.218 vs.7.133个月,P＝0.002 );对于无进展生存期,TAI +索拉非尼组明显优于索拉非尼组( 5.651 vs.3.067 个月,P ＝0.019).在TAI+索拉非尼组有4例患者后续进行了手术切除,其中1例的病理达到完全缓解.不良反应方面,两组均未出现治疗相关死亡,TAI+索拉非尼组出现更多的轻度神经毒性、骨髓抑制和肝功能损害,多数可恢复,仅有1例因骨髓抑制而终止治疗.结论 对于伴门脉主干或主分支癌栓的肝细胞癌,TAI联合索拉非尼可能是一种可行的、有前景的治疗方法.%Objective To compare the efficacy and safety of sorafenib combined with transcatheter arterial infu -sion (TAI) and sorafenib alone for hepatocellular carcinoma (HCC) with major portal vein carcinoma thrombosis .Meth-ods A total of 73 patients with HCC were randomly divided into sorafenib combined with TAI (SorTAI) group (n＝36) and sorafenib group (n＝37).The patients in the sorafenib group were treated with sorafenib 400 mg orally twice a day. The patients in the SorTAI group were treated with sorafenib 400 mg orally twice a day and TAI of oxaliplatin , leucovorin and 5-fluorouracil (FOLFOX), repeated every 21 days.The primary endpoint was the overall survival (OS).The sec-ondary endpoint was tumor response , progression free survival (PFS) and adverse events (AEs).Results The OS in the SorTAI group was significantly better than that in the sorafenib group (10.218 months vs.7.133 months, P＝0.002). The PFS in the SorTAI group was also significantly better than that in the sorafenib group (5.651 months vs.3.067 months, P＝0.019).In the SorTAI group, 4 patients achieved conversion to complete resection after the study treatment , and one of them experienced a pathological complete response .Treatment-related deaths did not occur in both groups . There were more mild neurotoxicity , bone marrow suppression and hepatic decompensation cases in the SorTAI group , but most of them can be recovered .Only one patient terminated treatment because of bone marrow suppression .Conclusion Sorafenib combined with TAI of FOLFOX might be a feasible and promising treatment for HCC with major portal vein carci -noma thrombosis.
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