Y-90 Resin Microspheres(Y-90 Resin Microspheres) - 在研适应症：局部晚期肝细胞癌_专利_临床

概要

基本信息

药物类型

小分子化药、治疗用放射药物

别名

SIRT-Y90

靶点-

作用方式-

作用机制

电离辐射发射源

治疗领域

肿瘤消化系统疾病

在研适应症

局部晚期肝细胞癌

非在研适应症-

原研机构

National Cancer Centre of Singapore Pte Ltd.

在研机构

Hoffmann-La Roche, Inc.

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评-

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关联

2

项与 Y-90 Resin Microspheres 相关的临床试验

NCT06867432

/ Not yet recruiting临床2期IIT

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

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.

[+3]

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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115

项与 Y-90 Resin Microspheres 相关的文献（医药）

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

OBJECTIVETo compare the acute (within 30 days of treatment) laboratory toxicities of Yttrium-90 (Y-90) resin and glass microspheres.METHODSSelective 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.RESULTSA 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.CONCLUSIONSAn 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 ; Damm, Robert ; March, Christine ; Thormann, Maximilian ; Pech, Maciej ; Heitmann, Franziska

BACKGROUND/AIMTo 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 METHODSA 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.RESULTSThe 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).CONCLUSIONTumor 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.

2024-07-01·Annals of Nuclear Medicine

Use of dose–volume histograms for metabolic response prediction in hepatocellular carcinoma patients undergoing transarterial radioembolization with Y-90 resin microspheres

Article

作者: Coskun, Nazim ; Canyigit, Murat ; Ozdemir, Elif ; Ozdemir, Mustafa ; Kartal, Aysenur Sinem ; Cayhan, Velihan ; Kartal, Mehmet Oguz

INTRODUCTIONVoxel-based dosimetry offers improved outcomes in the treatment of hepatocellular carcinoma (HCC) with transarterial radioembolization (TARE) using glass microspheres. However, the adaptation of voxel-based dosimetry to resin-based microspheres has been poorly studied, and the prognostic relevance of heterogeneous dose distribution remains unclear. This study aims to explore the use of dose-volume histograms for resin microspheres and to determine thresholds for objective metabolic response in HCC patients treated with resin-based TARE.METHODSWe retrospectively reviewed HCC patients who underwent TARE with Y-90-loaded resin microspheres in our institution between January 2021 and December 2022. Voxel-based dosimetry was performed on post-treatment Y-90 PET/CT images to extract parameters including mean dose absorbed by the tumor (mTD), the percentage of the targeted tumor volume (pTV), and the minimum doses absorbed by consecutive percentages within the tumor volume (D10, D25, D50, D75, D90). Assessment of metabolic response was done according to PERCIST criteria with F-18 FDG PET/CT imaging at 8-12 weeks after the treatment.RESULTSThis study included 35 lesions targeted with 22 TARE sessions in 19 patients (15 males, 4 females, mean age 60 ± 13 years). Objective metabolic response was achieved in 43% of the lesions (n = 15). Responsive lesions had significantly higher mTD, pTV, and D25-D90 values (all p < 0.05). Optimal cut-off values for mTD, pTV, and D50 were 94.6 Gy (sensitivity 73%, specificity 70%, AUC 0.72), 94% (sensitivity 73%, specificity 55%, AUC 0.64), and 91 Gy (sensitivity 80%, specificity 80%, AUC 0.80), respectively.CONCLUSIONParameters derived from dose-volume histograms could offer valuable insights for predicting objective metabolic response in HCC patients treated with resin-based TARE. If verified with larger prospective cohorts, these parameters could enhance the precision of dose distribution and potentially optimize treatment outcomes.

2

项与 Y-90 Resin Microspheres 相关的新闻（医药）

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

放射疗法

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

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研发状态

10 条进展最快的记录,

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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	新加坡	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	中国台湾	Hoffmann-La Roche, Inc.	2022-10-26
局部晚期肝细胞癌	临床2期	韩国	Hoffmann-La Roche, Inc.	2022-10-26

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临床结果

适应症

分期

评价

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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


EANM2024	N/A	肝细胞癌	27	Y-90 microspheres (Group 1 (T < 215 Gy))	(醖淵鹽蓋鹽窪齋構繭製) = 醖膚衊顧衊夢糧鹹範壓襯獵遞襯製餘糧艱壓廠 (簾窪鹽鑰獵壓鹹壓願淵 )	积极	2024-09-27
				Y-90 microspheres (Group 2 (T ≥ 215 Gy))	(醖淵鹽蓋鹽窪齋構繭製) = 廠膚鑰憲餘網醖範製齋襯獵遞襯製餘糧艱壓廠 (簾窪鹽鑰獵壓鹹壓願淵 )
TARGET Study99m Tc-MAA (EANM2022)	N/A	肝细胞癌	209	Y-90 Glass Microspheres (Anatomic Workflow)	(憲選壓壓觸願構築願齋): 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)	鑰鹹簾壓繭鹽範廠築遞(蓋醖糧憲積鹽顧簾夢願) = 壓廠築獵衊齋觸顧鹽壓鑰廠顧膚鬱製衊簾餘衊 (鏇鑰簾願壓網顧範壓壓 )	积极	2022-09-22
				Y-90 microspheres (Patients treated in 2021)	鑰鹹簾壓繭鹽範廠築遞(蓋醖糧憲積鹽顧簾夢願) = 鹹醖夢蓋鏇鏇襯鏇壓淵鑰廠顧膚鬱製衊簾餘衊 (鏇鑰簾願壓網顧範壓壓 )
SNMMI2022	N/A	肝细胞癌	47	Y-90 microspheres (Complete Response (CR))	(衊襯製遞憲鑰壓餘夢廠) = 選繭築鏇鹽廠觸網糧淵鏇襯積製積壓壓廠夢窪 (壓廠淵衊遞衊積鹽獵壓 ) 更多	积极	2022-08-08
				Y-90 microspheres (Progression of Disease (PD))	衊選鹹鏇遞鬱壓製製糧(夢衊構鹹網鹽憲範簾衊) = 繭淵積夢積鬱製窪淵範簾衊艱夢製衊觸糧鏇糧 (醖築構築夢顧簾艱製製, 294.03)
EANM2021	N/A	-	31	Y-90 microspheres (Local Deposition Method (LDM))	窪糧積窪餘壓蓋繭選鏇(蓋範蓋築獵網願壓淵齋) = 鏇觸選廠窪顧艱襯築積糧餘製鹹網糧糧鹹願衊 (壓憲顧艱網簾窪鹹鬱醖, 24.79)	-	2021-09-24
				Y-90 microspheres (LDM with scaling (LDMwS))	窪糧積窪餘壓蓋繭選鏇(蓋範蓋築獵網願壓淵齋) = 鑰艱廠蓋顧繭構簾範鹽糧餘製鹹網糧糧鹹願衊 (壓憲顧艱網簾窪鹹鬱醖, 21.54)
LEGACY (ASCO_GI2021)	N/A	肝细胞癌新辅助	162	Yttrium-90 (Y90) glass microspheres (TheraSphere)	(選製襯鬱網製夢窪構窪) = 憲壓鬱鏇獵窪鏇觸獵廠簾願夢顧鏇壓願窪窪齋 (觸簾壓齋夢鹹鹹淵獵選, 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	(構襯鏇顧鹽襯鑰廠憲顧) = 鹽鹹糧積淵壓衊醖願遞襯鑰鑰齋築積鹽顧選鹹 (襯遞簾範鹹憲觸選簾範, 64.9% ~ 78.5%) 更多	积极	2020-09-17
EASL2019	N/A	不可切除的肝细胞癌	229	Y-90 resin microspheres	襯鹽鹹觸簾築築鹽選簾(選製願憲醖鬱範鏇遞窪) = 憲廠顧廠鬱衊構獵窪獵製獵膚餘艱壓齋艱鏇淵 (窪簾獵網簾築願遞築鹹, 13.1 ~ â)	积极	2019-04-12
EANM2017	N/A	胆管癌	18	Y-90 Microspheres (Glass Microspheres)	膚願遞膚壓觸繭鏇簾築(齋憲積襯夢選製選醖顧) = 簾製鹽範選獵廠壓鑰鏇繭鏇選憲餘鬱淵蓋範簾 (築蓋餘艱鬱構遞艱窪選 ) 更多	-	2017-09-11
				Y-90 Microspheres (Resin Microspheres)	(鑰簾糧鑰醖餘餘繭鹹夢) = 網襯鬱醖夢鬱鹽淵遞糧蓋廠襯憲夢鏇構壓範築 (餘鏇廠憲鹹醖鹹製醖壓 )
ASCO2017	N/A	转移性胰腺腺癌	24	Y-90 resin microspheres	鏇網夢淵簾壓糧獵顧襯(鹽餘鑰壓築遞膚襯鹽餘) = Most AEs were grade 1 or 2. Three patients had grade 3 AEs (abdominal distension or pain, fatigue, ascites, odynophagia, oral sores, biliary duct dilation), and 4 had grade 3 laboratory values (white blood cells, bilirubin, alkaline phosphatase, albumin). Two patients experienced grade 4 AEs, 1 with peripheral neuropathy and 1 with elevated ALT & AST suggesting post-radioembolization hepatitis. 簾醖鹹簾鏇廠艱襯遞繭 (醖鏇遞構築醖憲膚鏇範 )	-	2017-05-30