经导管动脉化疗栓塞联合酪氨酸激酶抑制剂和卡瑞利珠单抗治疗不可切除的晚期肝细胞癌患者的安全性和有效性。
Safety and efficacy of transarterial chemoembolization combined with tyrosine kinase inhibitors and camrelizumab in the treatment of patients with advanced unresectable hepatocellular carcinoma.
机构信息
Intervention Ward One, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.
Department of Interventional, Weifang People's Hospital, Weifang, Shandong, China.
出版信息
Front Immunol. 2023 Jul 21;14:1188308. doi: 10.3389/fimmu.2023.1188308. eCollection 2023.
OBJECTIVE
This study was aimed to evaluate the efficacy and safety of transarterial chemoembolization combined with tyrosine kinase inhibitors and camrelizumab in the treatment of unresectable hepatocellular carcinoma and to explore a new therapeutic strategy for the treatment of advanced HCC.
PATIENTS AND METHODS
A total of 87 patients aged 18-75 years with at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (version 1.1) were included in the study. TACE was administered as needed, and camrelizumab and TKI medication were initiated within two weeks and one week after TACE, respectively. The primary endpoints were progression-free survival and objective response rate.
RESULTS
The 87 patients in this trial were last evaluated on September 28, 2022, and 35.8% were still receiving treatment at the data cutoff. A total of 34 patients (39.1%) died, and the median OS was not reached. The median PFS was 10.5 months (95% CI: 7.8-13.1). The ORR rate was 71.3% (62/87), and the DCR rate was 89.7% (78/87) per mRECIST. According to RECIST version 1.1, the ORR rate was 35.6% (31/87), and the DCR rate was 87.4% (76/87). Ten patients (11.5%) successfully underwent conversion therapy and all achieved R0 resection. Two patients achieved a complete pathological response, four achieved a major pathological response, and four had a partial response. All treatment-related adverse events were tolerated. No serious adverse events were observed, and no treatment-related deaths occurred.
CONCLUSIONS
TACE combined with TKI and camrelizumab was safe and effective in treating advanced HCC. Triple therapy may benefit patients with large tumor burden and portal vein cancer thrombus and is expected to provide a new treatment strategy for advanced HCC.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, identifier ChiCTR2000039508.
目的
本研究旨在评估经动脉化疗栓塞（TACE）联合酪氨酸激酶抑制剂（TKI）和卡瑞利珠单抗治疗不可切除肝细胞癌的疗效和安全性，并探索晚期 HCC 的新治疗策略。
患者和方法
本研究共纳入 87 名年龄在 18-75 岁之间、根据实体瘤反应评价标准 1.1（RECIST1.1）至少有一个可测量病灶的患者。根据需要进行 TACE 治疗，在 TACE 后两周和一周内分别开始给予卡瑞利珠单抗和 TKI 药物治疗。主要终点为无进展生存期（PFS）和客观缓解率（ORR）。
结果
本试验中的 87 例患者最后一次评估时间为 2022 年 9 月 28 日，数据截止时仍有 35.8%的患者正在接受治疗。共有 34 例（39.1%）患者死亡，中位总生存期（OS）未达到。中位 PFS 为 10.5 个月（95%CI：7.8-13.1）。根据 mRECIST，ORR 率为 71.3%（62/87），疾病控制率（DCR）为 89.7%（78/87）。根据 RECIST1.1，ORR 率为 35.6%（31/87），DCR 率为 87.4%（76/87）。10 例（11.5%）患者成功接受了转化治疗，均达到了 R0 切除。2 例患者获得完全病理缓解，4 例患者获得主要病理缓解，4 例患者获得部分缓解。所有治疗相关不良事件均可耐受。未观察到严重不良事件，也未发生与治疗相关的死亡。
结论
TACE 联合 TKI 和卡瑞利珠单抗治疗晚期 HCC 安全有效。三联疗法可能使肿瘤负荷大且门静脉癌栓的患者受益，有望为晚期 HCC 提供一种新的治疗策略。
临床试验注册
ClinicalTrials.gov，标识符 ChiCTR2000039508。
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