Efficacy and Safety of Yttrium-90 Microspheres Selective Internal Radiotherapy Combined with Immune Checkpoint Inhibitors and Anti-angiogenesis Drugs Sequential Hepatic Arterial Infusion Chemotherapy (HAIC) for Hepatocellular Carcinoma

To observe and evaluate the efficacy and safety of selective internal radiotherapy (SIRT) based on transarterial radioembolization with yttrium (90Y) microspheres combined with immune checkpoint inhibitors and anti-angiogenic-drug sequential hepatic arterial infusion chemotherapy (HAIC) for the treatment of initially unresectable hepatocellular carcinoma with transformation potential.

开始日期2025-03-01

申办/合作机构

天津市肿瘤医院（天津医科大学肿瘤医院）

NCT05377034

/ Recruiting临床2期IIT

A Multinational, Double-blind, Placebo-Controlled, Parallel Randomized Arms, Phase II Trial to Compare Safety and Efficacy of Selective Internal Radiation Therapy (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab) Versus Selective Internal Radiation Therapy (SIRT-Y90) Followed by Placebo in Patients With Locally Advanced Hepatocellular Carcinoma (HCC)

This is a multi-national, phase II, parallel-arm, double-blind, placebo-controlled, two-arm study designed to assess the efficacy and safety of SIRT-Y90 followed by atezolizumab plus bevacizumab [study arm], versus SIRT-Y90 followed by placebo [control arm] in patients with locally advanced Hepatocellular Carcinoma (HCC).

开始日期2022-10-26

申办/合作机构

National Cancer Centre of Singapore Pte Ltd.

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100 项与 Y-90 Resin Microspheres 相关的临床结果

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100 项与 Y-90 Resin Microspheres 相关的转化医学

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100 项与 Y-90 Resin Microspheres 相关的专利（医药）

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118

项与 Y-90 Resin Microspheres 相关的文献（医药）

2025-04-01·European Journal of Nuclear Medicine and Molecular Imaging

Prediction of left lobe hypertrophy with voxel-based dosimetry using integrated Y-90 PET/MRI after radioembolization of liver tumors with Y-90 microspheres

Article

作者: Kuru Oz, Digdem ; Soydal, Cigdem ; Celebioglu, Emre Can ; Bilgic, Mehmet Sadık ; Kir, Kemal Metin ; Demir, Burak ; Kucuk, Nuriye Ozlem

PURPOSE:

The aim of this study was to investigate the relationship between voxel-based dosimetric variables derived from Y-90 PET/MRI and hypertrophy observed in the left lobe after radioembolization and to investigate if there is any difference in hypertrophy induced by glass versus resin microspheres.

METHODS:

Voxel-based dosimetry-derived variables and their relationship with the change of the standardized future liver remnant (ΔFLR) was investigated with linear regression models. To compare and evaluate the discriminatory power of the dosimetric variables, ROC analyses were utilized. ΔFLR and kinetic growth rate (KGR) induced with glass and resin microspheres were compared using the Mann-Whitney U test.

RESULTS:

In this retrospective study, data of the 40 patients treated with Y-90 microspheres were evaluated. Among the several dosimetric variables, the mean perfused volume normal tissue dose (pDnorm), perfused normal tissue V90 (pV90), and pV100 values for glass microspheres; and the mean whole liver normal tissue dose (Dnorm), pDnorm, whole liver normal tissue V30 (nV30), nV40, and pV40 for resin microspheres had the highest relationship with ΔFLR. In the ROC analysis for glass microspheres, the optimal cut-offs to predict ΔFLR > 5% were 60.55 Gy for Dnorm, 94.21 Gy for pDnorm, 28.07% for pV90, and 24.98% for pV100. For resin microspheres, corresponding values were 23.20 Gy for Dnorm, 37.40 Gy for pDnorm, 31.50% for nV30, 24.50% for nV40, and 43.60% for pV40. No significant difference was observed between glass and resin microsphere-induced median ΔFLR, KGR values and atrophy of the right lobe.

CONCLUSION:

Following Y-90 radioembolization therapy with glass and resin microspheres applied to the right lobe of the liver, ΔFLR is correlated with pDnorm and Dnorm, but is also significantly related to various nV and pV values. In addition, the hypertrophy and kinetic growth rates observed with glass and resin microspheres were largely similar.

2025-04-01·ANNALS OF NUCLEAR MEDICINE

Comparing laboratory toxicity of selective intra-arterial radionuclide therapy for primary and metastatic liver tumors: resin versus glass microspheres

Article

作者: Eldem, Gonca ; Bozkurt, M Fani ; Soydaş-Turan, Başak ; Ugur, Omer ; Peynircioglu, Bora ; Volkan-Salanci, Bilge

OBJECTIVE:

To compare the acute (within 30 days of treatment) laboratory toxicities of Yttrium-90 (Y-90) resin and glass microspheres.

METHODS:

Selective intra-arterial radionuclide therapies (SIRTs) with Y-90 resin and glass microspheres were retrospectively reviewed. Liver-hematological data were collected at baseline and at 1 week and 1 month follow-up. The percentage change of laboratory data and the albumin-bilirubin (ALBI) score were calculated.

RESULTS:

A total of 219 SIRTs (n: 110 resin, n: 109 glass) from 177 patients were included. There was no difference in age, liver pathologies, extrahepatic disease, baseline liver function tests, and total blood counts between the two microsphere groups. Administered activity was higher in treatments with Y-90 glass microspheres (p < 0.001). An increase in serum liver enzymes was observed after treatment with both microspheres. The difference between the treatment groups was the higher percentage increase of AST and ALT at the first week following Y-90 glass treatment (p < 0.001). However, this situation was not observed after 1 month. No difference in the percentage change of other laboratory parameters was found between two groups. The number of patients with an increase [resin n: 24 (24.7%) vs glass n: 26 (27.1%), p: 0.711) and decrease [resin n: 13 (13.4%) vs glass n: 8 (8.3%), p: 0.258] in the ALBI grade after SIRT was similar among groups.

CONCLUSIONS:

An increase in liver enzymes was observed in the early period after SIRT with both microspheres. No significant difference in liver and hematological data was detected during early follow-up between the two groups, except that the percentage increase of AST and ALT were higher at the first week in the Y-90 glass group, possibly due to higher administered activity.

2025-01-01·IN VIVO

Lesion Volume Divided by ADC Measures Is an Independent Prognostic Marker in Colorectal Liver Metastasis Treated by Y90-radioembolization

Article

作者: Christ, Sebastian M ; Pech, Maciej ; Thormann, Maximilian ; Damm, Robert ; March, Christine ; Heitmann, Franziska

BACKGROUND/AIM:

To assess the ability of apparent diffusion coefficient (ADC) at baseline in predicting overall survival in patients who undergo Y90-radioembolization (Y90-RE) for liver-dominant metastatic colorectal cancer (mCRC) in the salvage situation.

PATIENTS AND METHODS:

A retrospective review of 411 lesions in 63 patients with refractory mCRC treated with Y90-RE was conducted. Manual region of interest (ROI) measurements were applied using a whole lesion and volume method. Minimum and mean ADC values were measured, and averages were calculated per patient. Ratios combining tumor volume and ADC were correlated with OS, and a receiver-operating characteristic (ROC) analysis defined a cut-off value. Cox regression analysis was performed, and the log-rank test confirmed prognostic cut-off levels for survival.

RESULTS:

The median survival was 6.4 months. Multivariate Cox regression identified tumor volume divided by minimum ADC (ADC_{tumor volume, min}) as an independent predictor of OS (HR=1.814, 95%CI=1.188-2.770, p=0.006). Neither ADCmin nor ADCmean were significantly associated with survival. Optimal prediction was identified with a ADC_{tumor volume, min} cut-off of 0.3673 arbitrary units (AU) yielding 76.0% sensitivity and 70.3% specificity. Patients with ADC_{tumor volume min} <0.3673 had a median OS of 10.4 months, compared to 4.7 months for those above the cut-off (p<0.001).

CONCLUSION:

Tumor volume divided by minimum ADC at baseline (ADC_{tumor volume, min}) was identified as an independent predictor of OS in mCRC scheduled for Y90-radioembolization in the salvage situation and may improve future patient selection.

项与 Y-90 Resin Microspheres 相关的新闻（医药）

2025-05-17

·ioncology

介愈肝胆丨深度解读钇-90微球选择性内放射治疗肝癌的长期疗效与安全性分析

点击蓝字关注我们前言介入治疗是一门新兴的临床学科，是微创医学的重要组成部分，独立于临床传统内科学和外科学之外的第三大临床学科。介入治疗在不开刀暴露病灶的情况下，借助先进的影像设备（如DSA、B超、CT等）在皮肤上作直径几毫米的微小通道，将特殊的穿刺针、导管等插到病变器官、组织，通过穿刺针或导管直接注入药物、栓塞剂或置入支架等方式对多种疾病进行治疗。为给广大同道提供肝病介入治疗的前沿进展，《国际肝病》携手四川大学华西医院罗薛峰副教授共同创办“国际肝病-介愈肝胆”栏目，每月定时分享介入领域的最新研究，传达规范治疗理念，追踪介入治疗的最新动态，以期对相关领域专家、研究人员及一线医务工作者的研究或工作有所裨益。文章背景钇-90微球选择性内放射治疗（Y90-SIRT）已纳入肝细胞癌（HCC）BCLC指南，用于早期肝癌治疗（Reig M, et al. J Hepatol. 2022; 76:681-93）。但在临床实践中，该治疗因对富血供病变具有根治潜力（Guiu B, et al. Cardiovasc Intervent Radiol. 2022; 45:1599-607），且能克服经动脉化疗栓塞术（TACE）的局限性（Brown AM, et al. Cancer Med. 2023; 12:2590-9；Lanza E, et al. PLoS ONE. 2020; 15:e0227711），故被广泛应用于晚期肝癌（Spreafico C, et al. J Hepatol. 2018; 68:724-32；Mazzaferro V, et al. Hepatology. 2013; 57:1826-37；Golfieri R, et al. Liver Cancer. 2019; 8:78-91）。此外，Y90-SIRT既可作为肝移植等待患者的有效降期治疗手段，也可作为一线治疗方案（Lopez-Lopez V, et al. Cancers (Basel). 2023; 15）。由于其广泛的临床应用，已报道的治疗结果及影响生存率的因素存在显著差异（Kolligs F, et al. JHEP Rep. 2023; 5:100633；Wagenpfeil J, et al. Front Radio. 2024; 4:1346550；Teyateeti A, et al. J Hepatocell Carcinoma. 2020; 7:117-31；Mosconi C, et al. J Clin Med. 2022; 11）。实际上，接受经Y90-SIRT治疗的患者常表现出高度异质性的临床特征（多与疾病分期相关），这可能影响治疗结果。因此，精准的患者筛选对治疗成功至关重要。European Journal of Nuclear Medicine and Molecular Imaging杂志于2025年3月在线发表了一篇题为《钇-90经动脉放射栓塞术治疗肝细胞癌患者的长期疗效与预后分析》的文章。该文章通过单中心回顾性分析，基于放射学应答及总生存期（OS）系统评估Y90-SIRT长期疗效与安全性，并探索生存预测生物标志物，为优化治疗决策提供循证依据。重要研究结果分析及其临床意义01患者筛选该研究连续筛查了2012年1月1日至2021年12月31日期间接受Y90-SIRT治疗的163例成年患者。符合入选标准的患者需经影像学或组织学确诊为HCC（允许联合诊断），且至少存在一个可测量病灶。纳入标准包括：随访时间＞2年；肝硬化或非肝硬化均可（若存在肝硬化，Child-Pugh分级需为A或B级）；体力状态评分（PS）0-1分。排除标准包括：存在肝外转移患者、接受Y90-SIRT治疗的患者，以及不符合纳入标准特征的患者（图1）。最终142例患者符合入选标准。该研究主要终点为评估Y90-SIRT治疗HCC的10年长期疗效，包括OS、影像学应答及安全性。次要终点包括确定OS的潜在预测因素，特别聚焦于Y90-SIRT剂量学分析，旨在探索辐射剂量、患者特征与治疗反应之间的相关性。图1. 研究人群纳入标准02患者基线特征在131例肝硬化患者中，122例（93.1%）为Child-Pugh A期，中位MELD评分为9（IQR：8-11），ALBI 1级和2级分别占43.5%（57/131）和54.2%（71/131）（表1）。根据BCLC分期，BCLC A期占28.9%（41/142），其中92.6%（38/41）为单发病灶。BCLC B期患者占35.2%（50/142），BCLC C期占35.9%（51/142），所有患者PS评分0-1分，伴或不伴门静脉癌栓（PVT），无肝外转移。133例具有剂量学数据的患者中，HCC靶病灶处方Y90活度均值为240.6 Gy（IQR：174.9-295.2），71.4%的患者使用树脂微球（表2）。表1. 研究人群的基线特征表2. 肿瘤相关特征和Y90-SIRT相关信息03放射学应答及安全性142例患者中44例（31.0%）达到完全缓解，55例（38.7%）部分缓解，13例（9.2%）疾病稳定，30例（21.1%）出现疾病进展。22例患者（16.8%）在Y90-SIRT治疗后Child-Pugh分级恶化，其中5例出现疾病进展，3例疾病稳定，5例部分缓解。手术后，38例患者（26.8%）出现临床副作用，主要是无力（16/38，42.1%）、腹痛（11/38，29.0%）和乳糜泻（8/38，21.0%）。迄今为止，尚未报告重大手术相关并发症。在单变量Cox回归模型中（表3），基线AFP水平≥15.7 ng/mL与生存率较差相关（HR=1.49，95%CI：1.02-2.20；P=0.041），治疗后AFP增加使死亡风险翻倍（HR=1.96，95%CI：1.28-2.98；P=0.002），Child-Pugh评分恶化也是如此（HR=1.88，95%CI：1.12-3.14；P=0.016）。表3. 按生存状态分组的患者特征分析CR：完全缓解；SD：疾病稳定；PR：部分缓解；PD：疾病进展；ΔaFP%：（治疗后甲胎蛋白值-治疗前甲胎蛋白值）/治疗前甲胎蛋白值×100（正值表示甲胎蛋白较基线水平的百分比升高）04总生存期Y90-SIRT后的中位OS为16.68月（IQR：9.24-39.6），1年、3年和5年生存率分别为63%、28%和13%。随访期结束时，31/142例患者（21.8%）仍然存活（图2）。Kaplan-Meier曲线（图3）表明完全放射学应答是OS的最强预测因素。图2. Y90-SIRT后5年OS的Kaplan-Meier生存图3. 显示生存率与完全放射学应答显著相关的Kaplan-Meier生存曲线（CR：完全缓解；PR：部分缓解；SD：疾病稳定；PD：疾病进展）05剂量与CR在74例（55.6%）接受≥234.6 Gy治疗的患者中，30例（40.5%）达到完全放射学缓解；在＜234.6 Gy的59例患者中，12例（20.3%）达到该终点（P=0.013）（图4）。按微球类型分层分析显示，高剂量组完全放射学缓解率更高，树脂微球组差异尤为显著（高剂量49.1% vs. 低剂量23.8%，P=0.012）。图4. 病灶平均剂量与完全缓解（CR）的总体相关性分析06多因素回归模型结果多因素Cox回归模型（表4）显示，与完全缓解患者相比，Y90-SIRT术后达到部分缓解、疾病稳定或进展的患者死亡风险增加一倍（HR=2.10，95%CI：1.25-3.53；P=0.005）。治疗后甲胎蛋白（AFP）升高（HR=1.91，95%CI：1.12-3.25；P=0.017）及肝功能恶化（HR=1.91，95%CI：1.02-3.60；P=0.044）与死亡风险显著相关。表4. 多因素Cox回归模型中与生存显著相关的特征07研究结论该研究证明Y90-SIRT可以延长肝癌患者的OS，揭示了肝脏相关因素（例如肝功能失代偿）与肿瘤相关因素（例如AFP和OS的变化）之间存在显著相关性。且无论Child-Pugh评分、BCLC分期或基线AFP水平如何，实现完全放射学缓解都显著提高生存率。此外，该研究数据表明放射剂量与肿瘤对Y90-SIRT的反应之间存在很强的相关性。未来展望这些结果表明，优化患者选择和改进Y90-SIRT技术可能会增加实现完全放射学应答的可能性，从而延长OS。亟需进一步的大规模前瞻性研究来优化治疗方案并提高Y90-SIRT的疗效和生存结果。翻译&解读寿佳龙四川大学华西医院消化内科；四川大学华西临床医学院硕士研究生专家简介罗薛峰四川大学华西医院医学博士、副教授、博士研究生导师四川省学术与技术带头人后备人选 Baveno VII门静脉高压共识专家组成员中国医师协会介入医师分会委员国家卫健委能力建设和继续教育介入医学专家委员会委员中华医学会肝病学分会肝病相关消化疾病协作组委员兼秘书中华医学会肝病学分会肝病基础医学与实验诊断协作组委员中国抗癌协会肿瘤微创治疗专委会门脉高压专委会常委四川省医促会消化分会常委兼秘书长于Hepatology，Journal of Hepatology，Radiology等SCI收录期刊发表论文60多篇作为主要执笔人参与《Baveno VII门静脉高压共识更新：门静脉高压的个体化管理》、《中国门静脉高压经颈静脉肝内门体分流术临床实践指南（2019版）》等多部国内外指南，参编Portal hypertension，Cardio-Hepatology等多部专著2018年UEG “Best Abstract Presentation Prize”，2019年”BEST of DDW“，2021年中国介入新锐，2021年中国静脉介入新锐2019年四川省科技进步一等奖，2022中华医学会科技进步一等奖往期回顾▶ 罗薛峰副教授：推动肝病介入治疗认知，促进学术交流▶介愈肝胆丨罗薛峰副教授：深入剖析法国经颈静脉肝内门体分流术指南（上）▶介愈肝胆丨罗薛峰副教授：深入剖析法国经颈静脉肝内门体分流术指南（下）▶介愈肝胆丨罗薛峰副教授：芳林新叶催陈叶，遇见小儿肝移植并发症介入治疗新进展▶介愈肝胆丨罗薛峰副教授：复杂门静脉介入治疗的最新进展与临床经验▶介愈肝胆丨罗薛峰副教授：精心细作，步步为营——先天性门体分流诊治进展▶介愈肝胆丨罗薛峰副教授分享CIRSE 2024上的“中国声音”▶介愈肝胆丨罗薛峰副教授：深度剖析TIPS在布加综合征治疗中的应用▶介愈肝胆丨罗薛峰副教授：胃静脉曲张出血治疗新进展——内镜下组织胶水注射相比介入治疗的效果评估▶介愈肝胆丨罗薛峰副教授：精准降低门静脉压力，平衡TIPS后腹水控制与肝性脑病风险▶介愈肝胆丨罗薛峰副教授：TIPS术后早期监测门脉压梯度变化可优化TIPS术后管理▶介愈肝胆丨罗薛峰副教授：腹水容积对肝癌TACE患者生存期的影响▶介愈肝胆丨 CARTO/PARTO治疗门静脉高压胃静脉曲张出血的10年真实世界研究解析解读寿佳龙审校罗薛峰（来源：《国际肝病》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

放射疗法临床结果

2024-09-16

·PRNewswire

Sirtex Medical Announces Certification of SIR-Spheres® Y-90 Resin Microspheres According to Medical Device Regulation (EU) 2017/745 and European Launch of the Innovative SIROS™ Delivery System

Sirtex brings an innovative liver cancer treatment delivery system to Europe, enhancing options for physicians and their patients. WOBURN, Mass., Sept. 16, 2024 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional treatment solutions, today announced that it has received certification according to Medical Device Regulation (EU) 2017/745 for SIR-Spheres® Y-90 resin microspheres and its delivery systems, paving the way for the European launch of the SIROS™ Delivery System. The EU MDR places greater emphasis on patient safety measures, risk management, post-market surveillance, and comprehensive data collection for medical devices seeking European market access. "Patient health and safety are always at the forefront of our work. That is why we are particularly proud to receive EU MDR certification for SIR-Spheres® Y-90 resin microspheres and its delivery systems, including SIROS™. This achievement underscores our commitment to delivering innovative products responsibly and ethically," said Matt Schmidt, CEO of Sirtex Medical Inc. "With the expansion of SIROS™ outside of the U.S., interventional radiologists in Europe now have an additional option to support patients battling metastatic colorectal cancer (mCRC) and unresectable hepatocellular carcinoma (HCC). This milestone reflects the outstanding efforts of our team, the rapid growth of our business, and the groundbreaking interventional oncology solutions we have developed." The SIROS™ Delivery System offers an intuitive, visual, and adaptable solution for physicians to administer SIR-Spheres® to liver cancer patients. Its easy-to-use design along with controlled administration provides physicians confidence in the Y-90 delivery. "As an interventional radiologist, I am excited about the future use of the SIROS™ Delivery System," shared Professor Thomas Helmberger, Head of Department of Radiology, Neuroradiology, and Minimal-Invasive Therapy at München Klinik Bogenhausen in Munich, Germany. "This device has an intuitive design and a precise control that will facilitate the administration of SIR-Spheres® Y-90 resin microspheres, and I am looking forward to incorporating it into my practice." About SIR-Spheres® in Europe SIR-Spheres® are medical devices used in selective internal radiation therapy (SIRT) and are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients refractory to or intolerant of chemotherapy. For a complete listing of indications, contraindications, side effects, warnings, and precautions, please consult the Instructions for Use at . About Sirtex Sirtex is a global healthcare company with offices in the U.S., Australia, Europe, and Asia, dedicated to improving patients' quality of life and longevity through innovative, minimally invasive cancer and embolization therapies. Sirtex's current leading product, SIR-Spheres® Y-90 resin microspheres, offers targeted radiation therapy for liver cancer. For more information, visit . SOURCE Sirtex Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

放射疗法

2022-09-15

·PRNewswire

Sirtex Medical secures positive approval of SIR-Spheres® Y-90 resin microspheres for HCC treatment in Brazil

The Brazilian National Agency of Supplementary Health recommends SIR-Spheres for the treatment of intermediate- and advanced-stage hepatocellular carcinoma WOBURN, Mass., Sept. 15, 2022 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of targeted liver cancer therapies, announced that the Brazilian National Agency of Supplementary Health (ANS) approved SIR-Spheres® Y-90 resin microspheres for the treatment of intermediate and advanced stage hepatocellular carcinoma (HCC) in Brazil. In an update to its List of Health Procedures and Events, ANS recommends SIR-Spheres for use in selective internal radiation therapy (SIRT), a minimally invasive treatment that delivers high doses of radiation directly to tumors while sparing surrounding healthy liver tissue. Sirtex received product approval from the Brazilian Health Regulatory Agency (ANVISA) for SIR-Spheres in 2014. "This milestone represents the close collaboration we have fostered with Brazilian colleagues, interventional radiologists and respected regulatory entities like ANS over the last six years," said Kevin R. Smith, Chief Executive Officer of Sirtex. "We celebrate the recognition of SIR-Spheres to advance care for HCC patients, and we also reaffirm our commitment to global growth and partnership for more effective cancer treatment worldwide." The proposals for incorporation into the ANS List of Health Procedures and Events underwent broad social participation and careful technical analysis by the ANS, using the methodology of health technology assessment, similar to England, Canada, Australia and Germany. In Brazil, liver cancer has the 11th-highest cancer incidence, representing 2.1% of new cases and 4.7% of total cancer-related deaths, which highlights the burden and severity of this disease. "The ANS recommendation of SIR-Spheres solidifies it as a valuable treatment option, especially since 76% of HCC patients in Brazil are diagnosed at an advanced stage when treatments of curative intent are no longer an option1," said Dr. Joaquim Maurício da Motta Leal Filho, President of the Brazilian Society of Interventional Radiology and Endovascular Surgery (SOBRICE). "As we continuously strive to improve outcomes for patients, we are proud of this achievement and feel gratitude to the many people who contributed to this decision." In addition to Brazil, SIR-Spheres are approved for use in Argentina, Australia, Switzerland, Turkey, and several countries in Asia for the treatment of unresectable liver tumors. In the U.S., SIR-Spheres Y-90 resin microspheres have a Pre-Market Approval (PMA) from the FDA and are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (floxuridine). 1 Fernandes GDS et al. Epidemiological and Clinical Patterns of Newly Diagnosed Hepatocellular Carcinoma in Brazil: the Need for Liver Disease Screening Programs Based on Real-World Data. J Gastrointest Cancer. 2021 Sep;52(3):952-958. doi: 10.1007/s12029-020-00508-7. Erratum in: J Gastrointest Cancer. 2020 Oct 26;: PMID: 32918274; PMCID: PMC8376733. About Sirtex Sirtex is a global healthcare business with offices in the U.S., Australia, Europe and Asia, working to improve outcomes in people with cancer. Sirtex's current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. For more information, visit . SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd. APM-GL-001-09-22 SOURCE Sirtex

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100 项与 Y-90 Resin Microspheres 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期肝细胞癌	临床2期	美国	Hoffmann-La Roche, Inc.	2022-10-26
局部晚期肝细胞癌	临床2期	中国	Hoffmann-La Roche, Inc.	2022-10-26
局部晚期肝细胞癌	临床2期	新加坡	Hoffmann-La Roche, Inc.	2022-10-26
局部晚期肝细胞癌	临床2期	中国台湾	Hoffmann-La Roche, Inc.	2022-10-26

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NEWS 人工标引	N/A	肝细胞癌	142	Y90-SIRT	醖構範壓鹽糧鑰衊鹹願(繭襯夢憲膚鑰獵憲壓膚) = 壓鏇鑰構鏇鹽構積鏇壓願艱醖壓鬱鑰糧繭廠憲 (壓繭繭觸鏇鹹繭構憲淵, 9.24 ~ 39.6) 更多	积极	2025-05-17
EANM2024	N/A	肝细胞癌	27	Y-90 microspheres (Group 1 (T < 215 Gy))	積簾齋繭壓選淵襯簾鹹(襯範鏇選簾襯壓獵壓築) = 鑰鑰蓋網鏇淵築顧餘選衊願壓衊選鑰鏇製鑰蓋 (艱淵願觸選構鑰糧願襯 )	积极	2024-09-27
				Y-90 microspheres (Group 2 (T ≥ 215 Gy))	積簾齋繭壓選淵襯簾鹹(襯範鏇選簾襯壓獵壓築) = 構夢鹹鏇遞網網鏇夢夢衊願壓衊選鑰鏇製鑰蓋 (艱淵願觸選構鑰糧願襯 )
TARGET Study99m Tc-MAA (EANM2022)	N/A	肝细胞癌	209	Y-90 Glass Microspheres (Anatomic Workflow)	鬱顧築遞構鬱糧獵鏇獵(糧顧鹽糧構蓋觸憲餘憲): odds ratio = 1.22 (95% CI, 1.01 ~ 1.49), P-Value = 0.044 更多	-	2022-09-22
				Y-90 Glass Microspheres99m Tc-MAA Microspheres (99m Tc-MAA SPECT Workflow)
Dosisphere 01 (EANM2022)	N/A	肝癌	-	Y-90 microspheres (Patients treated in 2019)	鹽鏇夢壓襯顧網遞艱網(齋積餘蓋廠範選選選製) = 網鹽淵膚齋蓋襯遞醖蓋艱襯築繭選範獵衊鏇願 (鹽鹽網積鏇積襯襯夢淵 )	积极	2022-09-22
				Y-90 microspheres (Patients treated in 2021)	鹽鏇夢壓襯顧網遞艱網(齋積餘蓋廠範選選選製) = 蓋鏇衊衊積觸顧糧艱獵艱襯築繭選範獵衊鏇願 (鹽鹽網積鏇積襯襯夢淵 )
SNMMI2022	N/A	肝细胞癌	47	Y-90 microspheres (Complete Response (CR))	鑰觸夢觸糧鬱餘繭積淵(構簾觸衊鑰鏇襯蓋膚蓋) = 醖鑰鑰醖餘膚願蓋築壓餘構獵餘遞鏇鹹艱簾鏇 (製構廠築艱艱積鏇鹹壓 ) 更多	积极	2022-08-08
				Y-90 microspheres (Progression of Disease (PD))	膚觸顧鬱鏇窪膚遞觸鏇(憲顧廠鏇簾衊觸鹽壓獵) = 顧糧憲遞顧願選顧淵築鏇積壓窪窪夢顧壓襯製 (積齋淵糧淵繭鏇壓選廠, 294.03)
EANM2021	N/A	-	31	Y-90 microspheres (Local Deposition Method (LDM))	膚壓顧艱醖憲鹹範選淵(積鏇願製鬱醖餘艱醖範) = 網餘淵壓醖醖醖齋簾齋觸衊遞鹽網齋簾艱網製 (範構鹽艱鹽鑰範觸鹹選, 24.79)	-	2021-09-24
				Y-90 microspheres (LDM with scaling (LDMwS))	膚壓顧艱醖憲鹹範選淵(積鏇願製鬱醖餘艱醖範) = 觸鹹構選壓積構範鹽廠觸衊遞鹽網齋簾艱網製 (範構鹽艱鹽鑰範觸鹹選, 21.54)
LEGACY (ASCO_GI2021)	N/A	肝细胞癌新辅助	162	Yttrium-90 (Y90) glass microspheres (TheraSphere)	顧艱齋觸繭積衊襯衊衊(廠壓襯網齋窪製憲顧衊) = 構襯衊範夢範遞構淵網膚鏇鏇鹽積醖觸獵願艱 (膚積構鹹簾顧網構鑰蓋, 64.9% ~ 78.5%) 更多	积极	2021-01-22
LEGACY (ESMO2020)	N/A	晚期肝细胞癌新辅助	162	Y90 glass microspheres	鹹膚範範壓淵窪鬱願選(膚窪鏇壓範壓膚糧範遞) = 齋膚鹹廠獵簾醖鏇構獵構壓觸憲繭廠範襯壓顧 (憲衊夢壓憲選積鬱簾糧, 64.9% ~ 78.5%) 更多	积极	2020-09-17
NEMESIS (ASCO2019)	N/A	晚期肝细胞癌	1,243	Selective Internal Radiation Therapy (SIRT)	廠憲獵選壓淵積鏇範鏇(製遞鹹鏇構鏇網鹽膚鑰) = Treatment-related AEs grades ≥3 were reported in 109/356 (30.6%) patients who received SIRT and 197/378 (52.1%) patients in the sorafenib arm (SIRveNIB and SARAH only, p = 0.0002) 範壓獵蓋艱窪積憲膚願 (鬱鬱鏇廠繭壓齋簾鹽鏇 ) 更多	积极	2019-05-26
				Sorafenib
SNMMI2019	N/A	肝细胞癌	-	TARE+sorafenib	顧憲淵蓋鏇鹽膚壓鹹簾(壓齋觸齋憲獵餘襯襯壓) = 顧鏇鏇遞艱製蓋築糧窪鬱製繭築鏇膚願壓鑰獵 (鏇製願鬱築顧鹹衊淵築, 9.7 ~ 17.2)	-	2019-05-21