[Translation] Post-marketing study of yttrium [90Y] resin microspheres in the treatment of patients with unresectable colorectal liver metastases who have failed standard therapy

主要目的：在经标准治疗失败的不可手术切除的结直肠癌肝转移患者中，研究者采用RECIST v1.1标准评价钇[90Y]树脂微球治疗后的肝特异性客观缓解率（ORR）

[Translation]

Primary objective: To evaluate the liver-specific objective response rate (ORR) after yttrium [90Y] resin microsphere therapy using RECIST v1.1 criteria in patients with unresectable colorectal liver metastases who failed standard treatment.

Start Date30 Nov 2023

Sponsor / Collaborator

Sirtex Medical Pty Ltd.

[+2]

DRKS00032073

/ CompletedNot ApplicableIIT

Radioembolization with holmium-containing microspheres: Use of the Holmium Platform for the treatment of patients with hepatocellular carcinoma

Start Date10 Jun 2022

Sponsor / Collaborator-

NCT03380130

/ CompletedPhase 2IIT

A Multicenter, Open-label, Single-arm Study of the Safety and Antitumoral Efficacy of Nivolumab After SIRT Using SIR-Spheres for the Treatment of Patients With HepatoCellular Carcinoma That Are Candidates for Locoregional Therapies

The purpose of this study is to evaluate the effect of the anti-programmed death 1 (PD-1) agent nivolumab following selective internal radiation therapy (SIRT) for patients with unresectable hepatocellular carcinoma (HCC).
SIRT using yttrium90-loaded microspheres is increasingly used to treat patients with HCC, particularly those that are not good candidates for transarterial chemoembolization or TACE. SIRT induces disease control (objective tumor remission or stabilization) in most patients while progression usually results from the growth of new lesions. SIR-Spheres are resin-made microspheres used for SIRT.
On the other hand, nivolumab is under clinical development for the treatment of more advanced HCC. Available data in patients that mostly had progression to other therapies and vascular involvement or metastatic disease show significant systemic antitumor activity that results in durable objective remissions and disease stabilizations.
Therefore, in patients with HCC that has not spread beyond the liver, the systemic action of nivolumab may improve the anti-tumor effect of SIRT. Furthermore, by inducing immunogenic tumor cell death, SIRT may have a synergistic effect with nivolumab.

Start Date11 Sep 2017

Sponsor / Collaborator

Clínica Universidad de Navarra

[+2]

100 Clinical Results associated with SIR-Spheres

100 Translational Medicine associated with SIR-Spheres

100 Patents (Medical) associated with SIR-Spheres

Literatures (Medical) associated with SIR-Spheres

01 Sep 2024·Health physics

Feasibility of Liver Transplantation after 90Y Radioembolization: Lessons from a Radiation Protection Incident

Article

Author: Lussey-Lepoutre, Charlotte ; Savier, Eric ; Roux, Charles ; Allaire, Manon ; Maisonobe, Jacques-Antoine ; Maksud, Philippe ; Soret, Marine ; Payen, Stéphane ; Kas, Aurélie

Abstract:

Radioembolization using 90Y is a growing procedure in nuclear medicine for treating hepatocellular carcinoma. Current guidelines suggest postponing liver transplantation or surgical resection for a period of 14 to 30 d after radioembolization to minimize surgeons’ exposure to ionizing radiation. In light of a radiation protection incident, we reevaluated the minimum delay required between radioembolization and subsequent liver transplantation. A patient with a hepatocellular carcinoma underwent a liver transplantation 44 h after undergoing radioembolization using 90Y (860 MBq SIR-Spheres). No specific radioprotection measures were followed during surgery and pathological analysis. We subsequently (1) evaluated the healthcare professionals' exposure to ionizing radiation by conducting dose rate measurements from removed liver tissue and (2) extrapolated the recommended interval to be observed between radioembolization and surgery/transplantation to ensure compliance with the radiation dose limits for worker safety. The surgeons involved in the transplantation procedure experienced the highest radiation exposure, with whole-body doses of 2.4 mSv and extremity doses of 24 mSv. The recommended delay between radioembolization and liver transplantation was 8 d when using SIR-Spheres and 15 d when injecting TheraSphere. This delay can be reduced further when considering the specific 90Y activity administered during radioembolization. This dosimetric study suggests the feasibility of shortening the delay for liver transplantation/surgery after radioembolization from the 8th or 15th day after using SIR-Spheres or TheraSphere, respectively. This delay can be decreased further when adjusted to the administrated activity while upholding radiation protection standards for healthcare professionals.

01 May 2024·European Journal of Nuclear Medicine and Molecular Imaging

MIDOS: a novel stochastic model towards a treatment planning system for microsphere dosimetry in liver tumors

Article

Author: Dawson, Robert J ; Wehrenberg-Klee, Eric ; Paganetti, Harald ; Bolch, Wesley E ; Bertolet, Alejandro ; Beekman, Chris ; Huesa-Berral, Carlos ; Withrow, Julia D

PURPOSE:

Transarterial radioembolization (TARE) procedures treat liver tumors by injecting radioactive microspheres into the hepatic artery. Currently, there is a critical need to optimize TARE towards a personalized dosimetry approach. To this aim, we present a novel microsphere dosimetry (MIDOS) stochastic model to estimate the activity delivered to the tumor(s), normal liver, and lung.

METHODS:

MIDOS incorporates adult male/female liver computational phantoms with the hepatic arterial, hepatic portal venous, and hepatic venous vascular trees. Tumors can be placed in both models at user discretion. The perfusion of microspheres follows cluster patterns, and a Markov chain approach was applied to microsphere navigation, with the terminal location of microspheres determined to be in either normal hepatic parenchyma, hepatic tumor, or lung. A tumor uptake model was implemented to determine if microspheres get lodged in the tumor, and a probability was included in determining the shunt of microspheres to the lung. A sensitivity analysis of the model parameters was performed, and radiation segmentectomy/lobectomy procedures were simulated over a wide range of activity perfused. Then, the impact of using different microspheres, i.e., SIR-Sphere®, TheraSphere®, and QuiremSphere®, on the tumor-to-normal ratio (TNR), lung shunt fraction (LSF), and mean absorbed dose was analyzed.

RESULTS:

Highly vascularized tumors translated into increased TNR. Treatment results (TNR and LSF) were significantly more variable for microspheres with high particle load. In our scenarios with 1.5 GBq perfusion, TNR was maximum for TheraSphere® at calibration time in segmentectomy/lobar technique, for SIR-Sphere® at 1-3 days post-calibration, and regarding QuiremSphere® at 3 days post-calibration.

CONCLUSION:

This novel approach is a decisive step towards developing a personalized dosimetry framework for TARE. MIDOS assists in making clinical decisions in TARE treatment planning by assessing various delivery parameters and simulating different tumor uptakes. MIDOS offers evaluation of treatment outcomes, such as TNR and LSF, and quantitative scenario-specific decisions.

01 Jul 2023·Cardiovascular and interventional radiology

Predictive Factors for Adverse Event Outcomes After Transarterial Radioembolization with Yttrium-90 Resin Microspheres in Europe: Results from the Prospective Observational CIRT Study.

Article

Author: Helmberger, Thomas ; Maleux, Geert ; Bilbao, José I ; Zeka, Bleranda ; Albrecht, Thomas ; Schaefer, Niklaus ; Kolligs, Frank ; Cianni, Roberto ; Pereira, Helena ; Munneke, Graham ; Bargellini, Irene ; de Jong, Niels ; Arnold, Dirk ; Sangro, Bruno ; Peynircioglu, Bora

BACKGROUND:

Using data collected in the prospective observational study CIRSE Registry for SIR-Spheres Therapy, the present study aimed at identifying predictors of adverse events (AEs) following transarterial radioembolization (TARE) with Yttrium-90 resin microspheres for liver tumours.

METHODS:

We analysed 1027 patients enrolled between January 2015 and December 2017 and followed up for 24 months. Four hundred and twenty-two patients with hepatocellular carcinoma (HCC), 120 with intrahepatic carcinoma (ICC), 237 with colorectal liver metastases and 248 with liver metastases from other primaries were included. Prognostic factors were calculated with a univariable analysis by using the overall AEs burden score (AEBS).

RESULTS:

All-cause AEs were reported in 401/1027 (39.1%) patients, with AEs associated with TARE, such as abdominal pain (16.6%), fatigue (17%), and nausea (11.7%) reported most frequently. Grade 3 or higher AEs were reported in 92/1027 (9%) patients. Reports on grade ≥ 3 gastrointestinal ulcerations (0.4%), gastritis (0.3%), radiation cholecystitis (0.2%) or radioembolization-induced liver disease (0.5%) were uncommon. Univariable analysis showed that in HCC, AEBS increased for Eastern Cooperative Oncology Group (ECOG) 0 (p = 0.0045), 1 tumour nodule (0.0081), > 1 TARE treatment (p = 0.0224), no prophylactic embolization (p = 0.0211), partition model dosimetry (p = 0.0007) and unilobar treatment target (0.0032). For ICC, > 1 TARE treatment was associated with an increase in AEBS (p = 0.0224), and for colorectal liver metastases, ECOG 0 (p = 0.0188), > 2 prior systemic treatments (p = 0.0127), and 1 tumour nodule (p = 0.0155) were associated with an increased AEBS.

CONCLUSION:

Our study confirms that TARE is a safe treatment with low toxicity and a minimal impact on quality of life.

News (Medical) associated with SIR-Spheres

16 Sep 2024

·www.prnewswire.com

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

Radiation Therapy

05 Aug 2024

·www.prnewswire.com

Sirtex Medical Launches SIR-Spheres® FLEXdose SELECT Delivery Program to Enable More Selective Y-90 Treatment Plans

Sirtex announces SIR-Spheres® portfolio expansion to include the FLEXdose SELECT 3mL vial configuration allowing for more patient-specific Y-90 selective treatment plans WOBURN, Mass., Aug. 5, 2024 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional treatment solutions, announced today the launch of its SIR-Spheres® FLEXdose SELECT Delivery Program, an innovative, new way to offer precise Y-90 selective internal radiation therapy for the treatment of metastatic colorectal cancer. SIR-Spheres® FLEXdose SELECT Delivery Program offers unparalleled flexibility by enabling tailored, patient-specific dosing from a single 3mL delivery vial. This program also marks the availability of 3mL SIR-Spheres® vials, which contain a reduced volume of microspheres (approximately 27 million compared to 44 million in the current 5mL vials). With up to five days pre-calibration available every day of the week, the novel Y-90 delivery program offers a vial of SIR-Spheres® designed for more selective treatment targeting. "We're pleased to introduce this latest innovation in Y-90 radioembolization therapy to treat a broader spectrum of tumor burden," said Matt Schmidt, CEO of Sirtex Medical Limited. "The SIR-Spheres® FLEXdose SELECT Delivery Program reflects our continued focus on listening to the needs of patients and physicians by enabling access to personalized Y-90 resin doses and expedited patient treatments." "I have found the SIR-Spheres® FLEXdose Program to be extremely helpful in treating my patients on a timely basis," explained Ripal Gandhi, M.D., a member of the Miami Cardiac & Vascular Institute and Miami Cancer Institute and the course director for the Symposium on Clinical Interventional Oncology. "With this program, I can personalize the Y-90 treatment for each of my patients using a product that is available every day of the week. I applaud Sirtex for investing resources in SIR-Spheres® FLEXdose SELECT and providing more options for physicians to optimize treatment strategies for even more patients." The new 3mL SIR-Spheres® Y-90 resin microspheres vials are available for order at [email protected]. For more information and details on how to incorporate the SIR-Spheres® FLEXdose SELECT Delivery Program into your practice, please contact Sirtex at [email protected]. About SIR-Spheres SIR-Spheres® are a medical device used in selective internal radiation therapy). SIR-Spheres® are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine). Caution: Federal (USA) law restricts this device for sale by or on the order of a physician. Consult the Instructions for Use () for a complete listing of indications, contraindications, side effects, warnings and precautions. 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 . SOURCE Sirtex Medical Inc.

Radiation Therapy

25 Mar 2024

·www.biospace.com

Sirtex Medical Appoints Matt Schmidt as New Chief Executive Officer and Board of Directors Member

WOBURN, Mass., March 25, 2024 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional treatment solutions, announced today the appointment of Matt Schmidt as chief executive officer and board of directors member, effective March 25. Since joining Sirtex in 2023, Schmidt has been an integral part of the company's executive leadership team, collaborating with senior leaders and shareholders to set corporate strategy, accelerate organizational performance, deliver strong results and build a winning culture. "I am confident Matt will advance Sirtex's vision of providing minimally invasive cancer and embolization therapies to more patients around the globe," said Dr. Weikun Tang, chairman of Grand Pharmaceutical Group Co., Ltd. "Matt's performance-driven leadership capabilities, as well as his commitment to partner with physicians to provide patients with innovative solutions, positions him as the right person to lead Sirtex into its next phase of growth. We are excited to work closely with Matt as Sirtex continues to create value for patients, physicians, employees and shareholders." With 20 years of industry experience and expertise, Schmidt joined Sirtex as executive vice president of global sales in February 2023 and was subsequently promoted to chief commercial officer in August. He previously held leadership positions at Abbott Vascular, including divisional vice president, where he was responsible for leading the company's U.S. coronary interventional cardiology device business, overseeing sales, marketing, commercial excellence and customer engagement. Prior to that role, Schmidt was divisional vice president and general manager for Abbott's vascular business in Japan. He earned an MBA from the University of Michigan and a bachelor's degree in accounting from Goshen College in Indiana. "I am optimistic about the future and honored to lead the Sirtex team during this exciting time in company history, especially given some of the transformative solutions we have brought to market over the last year," said Schmidt. "We are a patient-centered organization with talented employees who are dedicated to improving lives. I am very much looking forward to what we will achieve together." About Sirtex Sirtex is a global healthcare business with offices in the U.S., Australia, Europe and Asia, working to improve the quality and longevity of patients' lives by providing innovative minimally invasive cancer and embolization therapies. Sirtex's current lead offering in its product portfolio is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. For more information, visit .

Executive ChangeRadiation Therapy

100 Deals associated with SIR-Spheres

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatocellular Carcinoma	Germany	Sirtex Medical Pty Ltd.	22 Mar 2022
Liver Cancer	Germany	Sirtex Medical Pty Ltd.	22 Mar 2022
Colorectal Cancer	United States	Sirtex Medical Pty Ltd.	03 May 2002
Liver metastases	United States	Sirtex Medical Pty Ltd.	03 May 2002

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03380130 (NASIR-HCC, Pubmed) Manual	Phase 2	Hepatocellular Carcinoma	42	Nivolumab+SIR-Spheres	ltrjfpsoch(vsjxzvyapo) = qgynealhie japbwexqml (sogfuquiei ) View more	Positive	01 Nov 2022
NCT03380130 (NASIR-HCC, Biospace) Manual	Phase 2	Hepatocellular Carcinoma	-	Y-90 resin microspheres	nqjigotpec(obodxgnevt) = utbwctvpvd zfedxbfkzi (kvsfeczlba ) View more	Positive	14 Sep 2020
NCT03380130 (NASIR-HCC, ILCA2020)	Phase 2	Hepatocellular Carcinoma \| Unresectable Hepatocellular Carcinoma \| Advanced Hepatocellular Carcinoma ... View more	42	SIRT + Nivolumab	oiupfmpmgv(pbsdzhytlv) = iqhvsmkuga mlsjcrvmej (tlumxjbnnl ) View more	Positive	13 Sep 2020
NCT02416466 (HITM-SIR, Pubmed \| Cancer Gene Ther) Manual	Phase 1	Liver metastases CEA Positive	4	Anti-CEA CAR-T+SIR-Spheres	rqqyuolqry(uqccqlmwmn) = tqsigwhxgb briyayafov (lcsruznavk ) View more	Positive	01 May 2020
EANM2019	Not Applicable	Hepatocellular Carcinoma AFP \| PIVKA-II	140	resin 90Y-microspheres (Resin Y90-microspheres based on BSA methods)	cfpvolubkb(febrlfpafh) = psatvzqyzp vtaetumjdp (qemgciqlel, 0.26)	Positive	18 Sep 2019
				Resin Y90-microspheres (Resin Y90-microspheres based on personalized dosimetry)	cfpvolubkb(febrlfpafh) = ybfnkxpqax vtaetumjdp (qemgciqlel, 0.37)
EANM2018	Not Applicable	99m Tc-MAA \| 90 Y-PET/CT	2	90 Y-Microspheres (Patient 1)	yjawanmfps(heviiiafkc) = owigafgsul qzazdeytob (lemuszfbkb ) View more	-	18 Sep 2018
				90 Y-Microspheres (Patient 2)	yjawanmfps(heviiiafkc) = fxjceuxmzt qzazdeytob (lemuszfbkb ) View more
NCT02195011 (CTgov)	Phase 2	Colorectal Liver Metastases	26	Regorafenib+SIR-Spheres (Cohort 1: Regorafenib/SIR-Spheres/Regorafenib)	baltkdvies = vyqhqfohfk haazgqvcmu (oykefitfjj, hdfzjqlpgg - swntksvmrp) View more	-	12 Jul 2018
				Regorafenib+SIR-Spheres (Cohort 2: SIR-Spheres/Regorafenib)	baltkdvies = ankrnmipjl haazgqvcmu (oykefitfjj, gchereoxum - mjljvudmxb) View more
NCT01482442 (SARAH, Pubmed \| Lancet Oncol) Manual	Phase 3	Locally Advanced Hepatocellular Carcinoma	459	sorafenib+yttrium-90 resin microspheres	aytyvripsu(vbmtgulzeu) = sanoejdnmz edbeumsnpx (uwxcweudsf, 6.7 - 9.9) View more	Positive	01 Dec 2017
				sorafenib	aytyvripsu(vbmtgulzeu) = uykeypcuoi edbeumsnpx (uwxcweudsf, 8.7 - 11.4) View more
SNMMI2017	Not Applicable	Liver Cancer	-	TheraSphere	hppywtmyzo(tsvnbcfnzb) = tpxirtarxw pqwyvsnmro (wbugpllbrm )	-	24 May 2017
				TheraSphere (SIR-Spheres)	hppywtmyzo(tsvnbcfnzb) = pnbxnjhyga pqwyvsnmro (wbugpllbrm ) View more
ASTRO2014	Not Applicable	Metastatic Colorectal Carcinoma	60	Yttrium-90 resin microspheres	tvpsifhaio(enkcclfufe) = gpvuaymoeq luvpbehtli (aohygkdtte ) View more	Positive	01 Sep 2014

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