EASL 2025丨中国智慧闪耀欧洲肝癌峰会,八大摘要抢先看!(临床研究篇)

肿瘤瞭望消化时讯 发表时间:2025-02-20 16:53:26

编者按:当地时间2025年2月20日至22日,2025年欧洲肝脏研究学会(EASL)肝癌峰会将于法国巴黎隆重召开。作为肝癌领域的重要学术交流平台,中国学者将在这一国际舞台上展示多项重磅研究成果。从早期诊断到精准治疗,从基础研究到临床转化,中国团队以独特视角和创新方法,为全球肝癌防治贡献了不可忽视的“中国智慧”。

《肿瘤瞭望消化时讯》特别整理中国学者在EASL肝癌峰会上的八大研究摘要,其中5篇基础研究已在上一篇文章中进行介绍(点击此处阅读EASL 2025 丨中国智慧闪耀欧洲肝癌峰会,八大摘要抢先看!(基础研究篇)),本文介绍另外3篇临床研究,带您一览中国肝癌研究的最新突破与未来方向。


摘要号:PO3-19

索拉非尼联合经动脉化疗栓塞(TACE)对比索拉非尼单药治疗晚期肝细胞癌(HCC)的多中心、Ⅲ期、随机对照试验(SELECT研究)

Sorafenib combined with transarterial chemoembolization compared with sorafenib alone in advanced hepatocellular carcinoma(SELECT):a multicenter, phase 3, randomized, controlled trial

作者:韩国宏(西安国际医学中心医院)


背景:本研究旨在评估索拉非尼联合TACE对比索拉非尼单药治疗晚期HCC的疗效和安全性。
方法:SELECT研究是在中国12个中心开展的Ⅲ期随机对照试验(NCT01906216)。入组患者为晚期HCC(巴塞罗那临床肝癌分期C期)、Child-Pugh A级肝功能、美国东部肿瘤协作组体力状态评分为0或1。主要终点为总生存期(OS),次要终点包括无进展生存期(PFS)、客观缓解率(ORR)和安全性。
结果:共纳入2013年9月7日至2019年12月4日期间治疗的199例患者,其中99例进入联合治疗组,100例进入索拉非尼单药组。联合治疗组的方案依从率为86%(99例中的85例),索拉非尼单药组为56%(100例中的56例),中位随访时间为13.6个月。在意向治疗人群中,两组的OS无显著差异(联合治疗组为14.9个月,索拉非尼单药组为11.9个月;P=0.312)。然而,在符合方案人群中,联合治疗组的中位OS为14.6个月,而索拉非尼单药组的中位OS为7.4个月(P=0.001)。在意向治疗和符合方案人群中,PFS和ORR均达到预设终点。两组的不良事件总体发生率相似。
结论:本研究表明,索拉非尼联合经动脉化疗栓塞是治疗晚期HCC的有效干预手段。

摘要原文(滑动查看完整内容):

Background and aims: The prognosis of patients with advanced-stage hepatocellular carcinoma (HCC) is extremely poor. This trial was designed to evaluate the efficacy and safety of sorafenib combined with transarterial chemoembolization (TACE) compared with sorafenib alone for advancedstage hepatocellular carcinoma. 

Method: This phase 3, SELECT randomized, controlled trial was conducted at twelve centres in China (NCT01906216). Eligible patients were advanced-stage hepatocellular carcinoma (Barcelona Clinic Liver Cancer stage C), Child-Pugh class A liver disease, Eastern Cooperative Oncology Group performance statuses of 0 or 1. The primary endpoint was overall survival, and analysis was by intentionto-treat and per-protocol. Secondary endpoints included time to progression, tumor response rates and safety. Overall survival, and time to progression were analyzed with Kaplan-Meier analysis, hazard ratios (HRs) and 95% confidence intervals (CIs). We used R version 4.4.1 for statistical analyses. 

Results: Between September 7, 2013 and December 4, 2019, 199 patients were randomly assigned, 99 to the combination group and 100 to the sorafenib alone group. Protocol adherence was 86% (85 of 99 patients) in the combination group and 56% (56 of 100 patients) in the sorafenib alone group. At a median follow-up of 13.6 months (IQR 6.8-28.2), there was no significant difference in overall survival in the intention-to-treat population (14.9 months [95%CI 10.5-19.3] in the combination group versus 11.9 months [95%CI 9.0-14.8] in the sorafenib alone group; HR 0.862 [95%CI 0.645-1.150]; p=0.312). However, in per-protocol population, median overall survival was 14.6 months (95%CI 11.3-17.9 months) in the combination group, compared with 7.4 months (95%CI 4.3-10.5 months) in the sorafenib alone group (HR 0.539 [95%CI 0.378-0.769]; p=0.001). The endpoints of time to progression and objective tumor response rates were all met in the intention-to-treat and per-protocol population. The overall incidence of adverse events was similar between these two groups. 

Conclusion: Our findings indicate that sorafenib combined with transarterial chemoembolization is an effective intervention for advanced-stage hepatocellular carcinoma. The significance of overall survival of systemic drug combined with locoregional therapy for advanced-stage HCC management deserve further evaluation.


摘要号:PO6-18

125I放射性支架植入术后TACE联合免疫检查点抑制剂(ICIs)和分子靶向治疗(MTT)对于HCC合并门静脉癌栓患者的安全性与疗效(PATENCY Ⅱ)

TACE combined with ICIs plus MTT after 125I irradiation stent placement in patients with hepatocellular carcinoma and main portal vein tumor thrombosis (PATENCY Ⅱ)

作者:Junhao Mei(东南大学附属中大医院)


背景:HCC合并门静脉主干癌栓(Vp4 PVTT)的患者预后较差,目前的治疗方案效果有限。本研究旨在评估放射性支架植入术(ISP)后TACE联合ICIs及MTT作为一线治疗方案的安全性和疗效。
方法:这项研究纳入了2020年1月至2023年5月期间接受ISP、TACE、ICIs和MTT(四联治疗组,n=131)或仅接受ICIs和MTT(ICIs-MTT组,n=313)治疗的444例HCC合并Vp4 PVTT患者。主要终点为OS,次要终点包括PFS、ORR、PVTT缓解率、门静脉通畅率及安全性。
结果:含ISP的四联治疗组的中位OS(10.3个月,P=0.004)、PFS(6.1个月,P<0.001)及ORR(RECIST 1.1标准:52.8% vs. 27.7%;mRECIST标准:58.3% vs. 29.1%)均显著高于ICIs-MTT组。含ISP的四联治疗组的PVTT阳性缓解率也显著高于ICIs-MTT组(64.6% vs. 20.5%),支架中位通畅时间为10.4个月。含ISP的四联治疗组中37例患者(29.1%)和ICIs-MTT组中56例患者(25.5%)发生了≥3级不良事件(P=0.456)。
结论:在ISP术后,联合TACE、ICIs及MTT的治疗可显著延长HCC合并Vp4 PVTT患者的OS和PFS,且总体耐受性良好。

摘要原文(滑动查看完整内容):

Background and aims: Patients with hepatocellular carcinoma (HCC) and main trunk (Vp4) portal vein tumor thrombosis (PVTT) have a poor prognosis, and current treatment options provide limited benefits. We aimed to assess the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with immune checkpoint inhibitors (ICIs) plus molecular targeted therapy (MTT) after irradiation stent placement (ISP) as first-line treatment for these patients. 

Method: This multicenter retrospective cohort study enrolled 444 patients with HCC and Vp4 PVTT treated with either ISP, TACE, ICIs, and MTT (ISP-containing quadruple group, n = 131) or with ICIs and MTT (ICIs-MTT group, n = 313) between January 2020 and May 2023. Propensity score matching was used to balance the groups. The primary endpoint was overall survival (OS). The secondary endpoints included progression-free survival (PFS), objective response rate (ORR), PVTT response, patency of portal vein, and safety. 

Results: After propensity score matching (1:2), 127 patients from the ISP-containing quadruple group were matched with 220 patients from the ICIs-MTT group. The median OS (10.3 months, interquartile range [IQR]: 9.1-11.5 vs 8.6 months, IQR: 7.6-9.6; P = 0.004), PFS (6.1 months, IQR: 4.9-7.3 vs 3.5 months, IQR: 2.9-4.1; P < 0.001), and ORR (52.8% vs 27.7% with RECIST version 1.1; 58.3% vs 29.1% with mRECIST) were higher in the ISP-containing quadruple group than in the ICIs-MTT group. The ISP-containing quadruple group also demonstrated a higher PVTT positive response rate (64.6%) than the ICIs-MTT group (20.5%). Median stent patency was 10.4 months (IQR: 8.2-12.7). Grade ≥3 adverse events were observed in 37 patients (29.1%) in the ISP-containing quadruple group and 56 patients (25.5%) in the ICIs-MTT group (P = 0.456). 

Conclusion: Following ISP, treatment combining TACE with ICIs plus MTT can significantly prolong OS and PFS in patients with HCC and Vp4 PVTT and is generally well-tolerated.


摘要号:PO7-19

肝动脉灌注化疗(HAIC)联合卡瑞利珠单抗和仑伐替尼治疗晚期HCC的回顾性研究

Hepatic arterial infusion chemotherapy combined with camrelizumab and lenvatinib in the treatment of advanced hepatocellular carcinoma: a retrospective study

作者:Wei Dong(哈尔滨医科大学附属肿瘤医院)


背景:程序性细胞死亡蛋白-1(PD-1)抑制剂联合酪氨酸激酶抑制剂(TKIs)在不可切除的HCC治疗中取得了显著疗效。基于FOLFOX方案的HAIC在晚期HCC中也显示出良好的缓解率和生存获益。本研究旨在回顾性分析HAIC联合卡瑞利珠单抗和仑伐替尼治疗晚期HCC的疗效和安全性。
方法:研究纳入2020年11月至2023年2月在哈尔滨医科大学附属肿瘤医院接受至少三个周期HAIC联合卡瑞利珠单抗和仑伐替尼治疗的HCC患者。评估了患者特征、治疗方案、肿瘤反应、生存结局及不良事件。
结果:共有64例患者接受了HAIC联合仑伐替尼和卡瑞利珠单抗治疗。其中,21例患者的肿瘤转化为可手术切除的病灶,包括16例患者接受了手术切除,1例患者接受了射频消融并恢复良好,4例患者选择放弃手术。根据mRECIST标准,16例患者达到完全缓解,33例患者达到部分缓解,7例患者疾病稳定,8例患者疾病进展,ORR为76.6%。根据RECIST v1.1标准评估,ORR为54.7%。中位随访时间为17.9个月,中位PFS为15.73个月。所有不良事件均可耐受且可控,随访期间未报告治疗相关死亡。
结论:本研究表明,对于晚期HCC患者,HAIC联合仑伐替尼和卡瑞利珠单抗的治疗方案疗效良好且安全性可控。大多数患者的肿瘤病灶显著缓解,其中32.8%的患者转化为可切除状态,体现了三联方案显著的缩瘤效果。

摘要原文(滑动查看完整内容):

Background and aims: Programmed cell death protein-1 (PD-1) inhibitors, in combination with tyrosine kinase inhibitors (TKIs), have achieved significant therapeutic effects in unresectable hepatocellular carcinoma (HCC). Hepatic arterial infusion chemotherapy (HAIC) based on the FOLFOX regimen has also shown promising response rates and survival benefits for advanced HCC. This study aimed to retrospectively analyze the efficacy and safety of HAIC combined with camrelizumab (a PD-1 inhibitor) and lenvatinib in the treatment of advanced HCC. 

Method: This study included patients diagnosed with HCC who received at least three cycles of HAIC combined with camrelizumab and lenvatinib at Harbin Medical University Cancer Hospital from November 2020 to February 2023. We evaluated patient characteristics, treatment regimens, tumor responses, survival outcomes and adverse events (AEs). 

Results: A total of 64 patients received HAIC combined with lenvatinib and camrelizumab. Of these, the tumors of 21 patients were transformed into lesions that could be surgically resected including16 patients underwent surgical resection, 1 patient underwent radiofrequency ablation with satisfactory recovery, and 4 opted to forgo surgery. According to the mRECIST criteria, 16 patients achieved complete response, 33 patients achieved partial response, 7 patients had stable disease, and 8 patients had progressive disease, resulting in an overall response rate (ORR) of 76.6%. When assessed by RECIST v1.1, the ORR was 54.7%. Tumor response with different clinical stages was evaluated by RECIST v1.1 and revealed the best ORR in stages IB and IIIA. The median follow-up time was 17.9 months, and the median progression-free survival (PFS) was 15.73 months. Survival analysis indicated that PFS was significantly longer for Child-Pugh A patients compared to those with Child-Pugh B (P < 0.05), while no significant differences were noted in other subgroup analyses. All AEs were deemed tolerable and manageable, with no treatment-related deaths reported during follow-up. 

Conclusion: This study demonstrated that for patients with advanced HCC, the combined use of HAIC, lenvatinib and camrelizumab showed controllable safety and good efficacy. The tumor lesions of most patients were significantly relieved, with 32.8% of the patients were converted to a resectable state, reflecting the obvious tumor shrinkage effect of the triple regimen.

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