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EASL 2026 | 肝癌研究亮点:GALAXY-90实锤、超2年生存密码、超高龄靶免对决

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2026年欧洲肝病学会年会(EASL 2026)2026年5月27日-30日西班牙•巴塞罗那顺利召开。作为全球肝病学领域的学术盛会,本届大会汇聚国际顶尖专家学者,共同探讨肝病学、胃肠病学、移植外科及传染病学等领域的最新研究进展与临床实践突破。

大会设置前沿学术报告、高互动性研讨会及专题论坛,为与会者提供深度交流与专业提升的高端平台。为及时传递大会精华内容,肝胆相照平台全程跟踪报道,本篇精选肝癌领域热点研究进行整理,以传递大会的最新动态和精彩看点。

01 FRI-228-YI

肝细胞癌钇-90经动脉放射栓塞治疗后的剂量–反应关系及临床结局:GALAXY-90研究

Dose–response relationship and clinical outcomes after Yttrium-90 transarterial radioembolization for hepatocellular carcinoma: GALAXY-90 study

作者:Kaina Chen, Xinyu Chen, Aaron Kian Ti Tong, Kheng Choon Lim, Kelvin Siu Hoong Loke, Shay Lee Chong, Fiona Ni Ni Moe, Imperial Edeliza Santiago Ria, Yang Lu, David Chee Eng Ng, Apoorva Gogna, Richard Hoau Gong Lo, Sue Ping Thang, Brian Goh, Han Chong Toh, Choon Hua Thng, Wan Ying Chan, Shuting Han, Karaddi Venkatanarasimha Nanda Kumar, Sivanathan Chandramohan, Winnie Wing Chuen Lam, Kun Da Zhuang, Hian Liang Huang, Chow Wei Too, Butch Maulion Magsombol, Siou Sze Chua, Ashley Weng Yan Ng, Jade Shu Qi Goh, Evelyn Chiew, Cheryl Min En Chua, Rachel Xin Hui Teo, Pierce Chow

研究背景与目的▼

钇-90经动脉放射栓塞治疗(Y-90 TARE)随着更高放射剂量的应用,已从姑息性治疗逐渐发展为具有潜在根治意图的肝细胞癌(HCC)治疗方式。

GALAXY-90(Generalized Analysis of Locoregional Approach by eXamining outcomes with Yttrium-90)研究是亚洲首项相关研究。由于亚洲地区更常见大体积 HCC,本研究旨在评估不同肿瘤放射吸收剂量范围内的剂量–反应关系,并比较两个不同疗效评估时间窗口下的治疗结局。

Background and aims:Yttrium-90 transarterial radioembolization (Y-90 TARE) has evolved from a palliative treatment to a potentially curative therapy for hepatocellular carcinoma (HCC) with the use of higher radiation doses. The Generalized Analysis of Locoregional Approach by eXamining outcomes with Yttrium-90 (GALAXY-90) study is the first Asian study, conducted in a population where larger HCC tumors are more prevalent, to evaluate the dose–response relationship across a broad range of tumor radiation doses within two different evaluation time windows.

研究方法▼

本研究回顾性分析了 2019–2024 年期间于新加坡国家癌症中心及新加坡中央医院接受 Y-90 TARE 治疗的连续性单发 HCC 患者,可伴或不伴门静脉侵犯。肿瘤疗效采用局部 mRECIST 标准评估。最佳客观缓解率(BORR)及最佳疾病控制率(BDCR)分别在治疗后 ≤6个月及 ≤9个月进行评估。总生存期(OS)及无进展生存期(PFS)采用 Kaplan–Meier 法分析。安全性依据 CTCAE v5.0 标准进行不良事件(AE)分级。

Method:We retrospectively analyzed consecutive patients with solitary HCC, with or without portal vein invasion, who were treated with Y-90 TARE at the National Cancer Centre Singapore and Singapore General Hospital between 2019 and 2024. Tumor response was evaluated using localized mRECIST criteria. Best objective response rate (BORR) and best disease control rate (BDCR) were assessed within ≤6 months and ≤9 months after treatment. Overall survival (OS) and progression-free survival (PFS) were analyzed using the Kaplan–Meier method. Safety was assessed according to adverse events (AEs) graded by CTCAE v5.0.

研究结果▼

研究期间共有 429 例患者接受 Y-90 治疗,其中 110 例纳入最终分析。肿瘤中位直径为 6.6 cm。预测平均吸收剂量分为四组:<120 Gy、120–200 Gy、200–300 Gy 及 ≥300 Gy,中位剂量为 191 Gy(范围 41.2–647.8 Gy)。

从 ≤6个月到 ≤9个月评估窗口,总体最佳客观缓解率(BORR)由 78.0% 提升至 91.7%,且在四个剂量区间中均呈现显著趋势(p = 0.003;p = 0.019)。完全缓解率(CR)则由 ≤6个月时的 13.8% 提高至 ≤9个月时的 34.9%。

剂量 ≥200 Gy 的患者,其 BORR 显著高于 <200 Gy 组(≤6个月时 p = 0.002;≤9个月时 p = 0.004)。在配对时间窗亚组分析(n = 88)中,6–9个月期间出现的“迟发应答者”是 BORR 提升的重要来源(p = 0.002)。

总体最佳疾病控制率(BDCR)维持在 99.0%,在 ≥120 Gy 剂量组中达到 100%(p = 0.174)。中位 OS 与 PFS 分别为 44个月(95% CI:38–61)和 16个月(95% CI:13–26)。

不良事件发生率较低,且未观察到明显剂量依赖性(p > 0.05)。

Results:Among 429 patients who received Y-90 during the study period, 110 patients were included in the final analysis. The median tumor size was 6.6 cm. Predicted mean radiation doses were stratified into four groups: <120 Gy, 120–200 Gy, 200–300 Gy, and ≥300 Gy, with a median dose of 191 Gy (range 41.2–647.8 Gy).

From the ≤6-month to the ≤9-month evaluation window, overall BORR improved from 78.0% to 91.7%, with significant trends observed across the four dose intervals (p = 0.003; p = 0.019). Complete response rates increased from 13.8% to 34.9% between the ≤6-month and ≤9-month evaluations.

Radiation doses ≥200 Gy achieved significantly higher BORR compared with doses <200 Gy (p = 0.002 at ≤6 months; p = 0.004 at ≤9 months). In the paired-window subset analysis (n = 88), late responders between 6 and 9 months accounted for the improvement in BORR (p = 0.002).

Overall BDCR remained 99.0%, reaching 100% in patients receiving doses ≥120 Gy (p = 0.174). Median OS and PFS were 44 months (95% CI 38–61) and 16 months (95% CI 13–26), respectively.

Adverse events were infrequent and showed no dose-dependent relationship (p > 0.05).

研究结论▼

GALAXY-90 研究提示,对于大体积 HCC,≥200 Gy 可能是获得最佳肿瘤应答且不增加毒性的关键剂量阈值。将疗效评估随访延长至 9个月,有助于识别迟发应答患者,支持在 HCC 的 Y-90 治疗中采取“阈值剂量递增 + 延长疗效评估”的策略,从而获得更高的客观缓解率。

Conclusion: The GALAXY-90 study identified ≥200 Gy as a threshold associated with optimal tumor response without increased toxicity in patients with large HCC. Extending radiological follow-up to 9 months enabled identification of late responders, supporting a treatment strategy of threshold-dose escalation combined with prolonged response assessment after Y-90 therapy for HCC, thereby achieving high objective response rates.

02 FRI-231

接受非根治性治疗的肝细胞癌患者中超过两年生存的临床决定因素

Clinical determinants of survival beyond two years in HCC patients receiving non-curative treatment

作者:Burcu Gürbüz, Mustafa Utku Maraslı, Hasan Sahin, Muhammet Furkan Çakmak, Bengi Ozturk, Taylan Kav, Onur Keskin

研究背景与目的▼

肝细胞癌(HCC)是导致癌症相关死亡的重要原因之一。对于无法接受根治性治疗的患者,真实世界中的临床结局存在较大异质性,其中部分患者可获得超出预期的长期生存。本研究旨在阐述接受非根治性一线治疗且自诊断后生存≥2年的 HCC 患者的临床特征,并探索长期生存的预测因素。

Background and aims:Hepatocellular carcinoma (HCC) is a leading cause of cancer mortality. In patients not eligible for curative therapy, outcomes remain heterogeneous in real-world populations, and a subset of patients experience unexpectedly prolonged survival. We aimed to describe the clinical profile of patients who survived ≥2 years from diagnosis while managed with non-curative first-line therapy, and to identify predictors of long-term survival.

研究方法▼

本研究回顾性纳入 2015年1月至2023年9月期间于哈切特佩大学消化与肝病科随访的 HCC 患者。在 349 例患者中,282 例接受了非根治性一线治疗。长期生存定义为总生存期(OS)≥2年,并采用逐步后退法多因素 Logistic 回归分析长期生存的相关预测因素。

Method:We retrospectively included HCC patients followed at Hacettepe University Gastroenterology and Hepatology Clinic between January 2015–September 2023. Of 349 patients, 282 received non-curative first-line therapy. Long-term survival was defined as overall survival (OS) ≥2 years; predictors were assessed by backward stepwise multivariable logistic regression.

研究结果▼

共纳入 282 例接受非根治性治疗的患者。患者中位年龄为 65 岁(25–90岁),中位总生存期为 15个月(0–168个月)。其中,104/282(36.9%)患者 OS ≥2年,178/282(63.1%)患者 OS <2年。

研究队列以男性为主(218/282,77.3%),但性别与 OS ≥2年无显著相关性(p = 0.175)。

单因素分析显示,长期生存患者更常见以下特征:ECOG 评分 0–1(85.6% vs 62.9%;p < 0.001)、诊断时较少存在肿瘤血栓(23.1% vs 43.3%;p < 0.001)、最大病灶 <5 cm(76.0% vs 50.0%;p < 0.001)、GGT <80(52.9% vs 30.9%;p < 0.001)、更多接受局部区域治疗(RFA/TARE/TACE)(87.5% vs 71.3%;p = 0.001)、MASH 病因更常见(15.4% vs 7.9%;p = 0.048),以及血小板 <150 × 10⁹/L(60.6% vs 39.3%;p < 0.001)。

ROC 分析显示,149.5 × 10⁹/L 为预测 OS ≥2年的最佳血小板截断值。

在 274/282(97.2%)例具有完整协变量数据的患者中进行了 Logistic 回归分析,其中 OS ≥2年患者 99 例,OS <2年患者 175 例。

最终逐步回归模型显示,与 OS ≥2年独立相关的因素包括:ECOG 0–1(vs 2–3)OR 3.12(95% CI 1.59–6.12;p = 0.001)、GGT <80(vs ≥80)OR 2.35(95% CI 1.35–4.10;p = 0.003),以及血小板 <150 × 10⁹/L(vs ≥150)OR 1.92(95% CI 1.09–3.33;p = 0.026)。

肿瘤直径 <5 cm(OR 1.76;95% CI 0.96–3.24;p = 0.067)以及无肿瘤血栓(OR 1.74;95% CI 0.96–3.16;p = 0.068)则呈边缘统计学意义。

Results:A total of 282 patients receiving non-curative treatment were included. Median age was 65 years (25–90) and median OS was 15 months (0–168). Overall, 104/282 (36.9%) had OS ≥2 years and 178/282 (63.1%) had OS <2 years. The cohort was predominantly male (218/282, 77.3%); sex was not associated with OS ≥2 years (p = 0.175). In univariate analysis, long-term survivors more often had ECOG 0–1 (85.6% vs 62.9%; p < 0.001), less tumor thrombus at diagnosis (23.1% vs 43.3%; p < 0.001), largest lesion <5 cm (76.0% vs 50.0%; p < 0.001), GGT <80 (52.9% vs 30.9%; p < 0.001), locoregional modalities (RFA/TARE/TACE) (87.5% vs 71.3%; p = 0.001), MASH etiology (15.4% vs 7.9%; p = 0.048) and platelet <150 × 10⁹/L (60.6% vs 39.3%; p < 0.001). On ROC analysis, platelet 149.5 × 10⁹/L was the optimal cut-off for OS ≥2 years. Logistic regression was performed in 274/282 (97.2%) with complete covariates (OS ≥2 years: 99; OS <2 years: 175). In the final stepwise model, independent associations with OS ≥2 years were ECOG 0–1 (vs 2–3) OR 3.12 (95% CI 1.59–6.12; p = 0.001), GGT <80 (vs ≥80) OR 2.35 (95% CI 1.35–4.10; p = 0.003), and platelet <150 × 10⁹/L (vs ≥150) OR 1.92 (95% CI 1.09–3.33; p = 0.026). Tumor size <5 cm (OR 1.76; 95% CI 0.96–3.24; p = 0.067) and absence of tumor thrombus (OR 1.74; 95% CI 0.96–3.16; p = 0.068) showed borderline significance.

研究结论▼

在本队列接受非根治性治疗的 HCC 患者中,超过三分之一的患者生存时间≥2年。长期生存与更好的体能状态(ECOG 0–1)、较低 GGT 水平及较低血小板水平独立相关,提示接受非根治性一线治疗的 HCC 患者中可能存在一种具有特殊临床特征的“长期生存者”表型。

Conclusion:  In this cohort of non-curatively treated HCC patients, more than one-third survived ≥2 years. Long-term survival was independently associated with better performance status (ECOG 0–1), lower GGT, and lower platelet, suggesting a distinct long-survivor phenotype among patients receiving non-curative first-line therapy.

03 FRI-237

超高龄肝细胞癌患者的一线治疗:仑伐替尼与阿替利珠单抗-贝伐珠单抗的疗效比较

First-line therapy in super-older adults with hepatocellular carcinoma: comparative effectiveness of Lenvatinib versus Atezolizumab-Bevacizumab

作者:Masamichi Kimura, Koji Nishikawa, Jun Imamura, Kiminori Kimura

研究背景与目的▼

由于关键性临床试验大多未纳入超高龄(≥80岁)肝细胞癌(HCC)患者,目前针对该人群一线系统治疗的循证依据仍较有限。本研究旨在比较仑伐替尼(LEN)与阿替利珠单抗联合贝伐珠单抗(Atezo + Bev)在超高龄 HCC 患者中的真实世界疗效与安全性,并评估 LEN 治疗中早期剂量递送情况,即 8 周相对剂量强度(relative dose intensity,RDI)是否能够对生存结局进行分层。

Background and aims:Evidence guiding first-line systemic therapy in super-older adults (≥80 years) with hepatocellular carcinoma (HCC) is scarce, as pivotal trials largely excluded this age group. We aimed to compare the real-world effectiveness and safety of lenvatinib (LEN) and atezolizumab + bevacizumab (Atezo + Bev) in this population and to assess whether early dose delivery, expressed as 8-week relative dose intensity (RDI), stratifies survival outcomes with LEN.

研究方法▼

本研究回顾性分析了 2018年5月至2025年8月期间接受一线 LEN(n = 30)或 Atezo + Bev(n = 26)治疗的 56 例 ≥80 岁不可切除/晚期 HCC 连续患者。所有患者均为 Child–Pugh A 级肝功能,ECOG 体能状态评分为 0–1。主要研究终点为总生存期(OS),次要终点包括无进展生存期(PFS)及不良事件(AEs)。在 LEN 组中,研究预设了第56天 Landmark 分析,以评估 8 周 RDI(≥75% vs <75%)与 OS 的关系,从而减少 immortal-time bias。生存分析采用 Kaplan–Meier 法及 log-rank 检验,并结合 12 个月限制性平均生存时间(RMST)进行补充分析。

Method:We retrospectively analyzed 56 consecutive patients aged ≥80 years with unresectable/advanced HCC who initiated first-line LEN (n = 30) or Atezo + Bev (n = 26) between May 2018 and August 2025. All patients had Child–Pugh A liver function and ECOG 0–1 performance status. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS) and adverse events (AEs). A prespecified Day-56 landmark analysis was performed in the LEN group to evaluate the association between 8-week RDI (≥75% vs <75%) and OS, mitigating immortal-time bias. Survival was analyzed using Kaplan–Meier and log-rank tests, supplemented by restricted mean survival time (RMST) at 12 months.

研究结果▼

LEN 组中位 OS 为 14.7 个月,Atezo + Bev 组为 10.7 个月(HR 0.82,95% CI 0.45–1.52;p = 0.52)。中位 PFS 分别为 6.7个月与 9.7个月(HR 1.22,95% CI 0.67–2.23;p = 0.51)。

LEN 组的客观缓解率(ORR)和疾病控制率(DCR)分别为 23% 和 67%,Atezo + Bev 组分别为 15% 和 77%。

在 LEN 队列中,20% 的患者达到 8 周 RDI ≥75%,且该亚组 OS 显著延长(30.8个月 vs 14.7个月;HR 0.34,95% CI 0.14–0.80;p = 0.019)。在 12 个月时,RMST 差值(ΔRMST)为 +32 天,倾向于高 RDI 的 LEN 治疗组。

3级及以上不良事件在 LEN 组和 Atezo + Bev 组中的发生率分别为 37% 和 50%,且均未出现治疗相关死亡。LEN 组更常见厌食和腹泻,而水肿及消化道出血仅见于 Atezo + Bev 组。

Results:Median OS was 14.7 months with LEN and 10.7 months with Atezo + Bev (hazard ratio [HR] 0.82, 95% CI 0.45–1.52; p = 0.52). Median PFS was 6.7 vs 9.7 months, respectively (HR 1.22, 95% CI 0.67–2.23; p = 0.51). Objective response and disease-control rates were 23%/67% for LEN and 15%/77% for Atezo + Bev.

In the LEN cohort, an 8-week RDI ≥75% was achieved in 20% of patients and was associated with markedly prolonged OS (30.8 vs 14.7 months; HR 0.34, 95% CI 0.14–0.80; p = 0.019). At 12 months, RMST difference (ΔRMST) was +32 days favoring high-RDI LEN.

Grade ≥3 adverse events occurred in 37% of the LEN group and 50% of the Atezo + Bev group, without treatment-related deaths. Anorexia and diarrhea were more frequent with LEN, while edema and gastrointestinal bleeding occurred only with Atezo + Bev.

研究结论▼

在超高龄 HCC 患者中,LEN 与 Atezo + Bev 展现出相似的真实世界疗效与耐受性。值得注意的是,在 LEN 治疗过程中维持较高的早期剂量强度(8 周 RDI ≥75%)可识别出生存显著改善的患者亚群。

这些结果提示,早期剂量强度可作为优化 ≥80 岁脆弱 HCC 患者系统治疗的重要实用性生物标志物,并支持一种基于剂量递送的治疗策略:在 LEN 治疗中尽量维持较高的早期 RDI;若无法维持该目标,则应及时考虑转换为 Atezo + Bev 治疗。

Conclusion: Among super-older adults with HCC, LEN and Atezo + Bev demonstrated comparable real-world efficacy and tolerability. Importantly, maintaining early dose delivery (8-week RDI ≥75%) under LEN identified a subgroup with significantly improved survival. These findings highlight early dose intensity as a pragmatic biomarker for optimizing systemic therapy in frail patients aged ≥80 years and support a dose-delivery-guided treatment algorithm: maintain high early RDI with LEN, and consider timely transition to Atezo + Bev if this target cannot be sustained.

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Tags: EASL 2026 | 肝癌研究亮点:GALAXY-90实锤、超2年生存密码、超高龄靶免对决  

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