[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.

[+1]

DRKS00032073 / CompletedNot Applicable

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

Start Date10 Jun 2022

Sponsor / Collaborator-

NCT04374903 / WithdrawnNot ApplicableIIT

Hydroxychloroquine in Combination With Sirolimus and Dexamethasone for Treating COVID-19 PatiEnts: A Pilot, Multicenter Randomized Open-Label Trial

COVID-19 caused an unprecedented international crisis. There is an urgent need for an effective regimen to cure this illness. Anecdotal data and some prospective results suggested a role of antimalarial drugs (chloroquine and hydroxychloroquine) in the treatment of this disease with best available data showing value of adding azithromycin. Based on drug repurposing studies done by our team and others, we identified the autophagy/apoptosis pathway as a major target for intervention. Based on in-silico and in-vitro models, sirolimus was identified as the drug that deserves urgent prioritization. The rational for combining sirolimus and hydroxychloroquine is explained in details in the study background below and a short video prepared by study PI (https://youtu.be/-zlOMXJp2hg). The evidence for using sirolimus for influenza is emphasized by a RCT that showed reduction of mechanical ventilation time by 50% (7 days on sirolimus arm vs 15 days on oseltamivir/steroids arm). Safe administration in human subjects is illustrated by multiple phase I/II clinical trials, performed in patients with cancer. COVID19-HOPE trial will randomize patients to 2 arms: HCQ/AZ (Arm A) and HCQ/SIR (Arm B). The main inclusion criteria is an RT-PCR test confirming infection with SARS-CoV-2 along with objective clinical criteria of disease (fever, tachypnea and/or hypoxemia). The primary endpoint of study will be Time To Clinical Improvement (TTCI), defined as time from randomization to resolution of the clinical features mentioned above (no fever, no tachypnea and no hypoxemia). In addition, secondary endpoints will include clinical failure by day 28 (need for intubation and/or death), QT interval prolongation, and adverse events. The estimated NNT based on Wilcoxon Mann Whitney comparison of TTCI in study arms is 58 patients (29 each arm). The study includes an adaptive plan, meaning that after different time points the study results will be evaluated and the NNT and randomization scheme (1:1 vs. others) will be evaluated and submitted to the IRB. Also, if one arm proves to be of no value, another regimen might be introduced based on available data. The study will recruit patients for a year and once approved by IRB and JFDA attempts to recruit other centers will be made (including national and regional centers).

Start Date01 Apr 2022

Sponsor / Collaborator

King Hussein Cancer Center

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 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 ; Arnold, Dirk ; de Jong, Niels ; 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.

01 Jul 2022·Cardiovascular and interventional radiologyQ3 · MEDICINE

GAUCHO - Trial Genicular Artery Embolization Using Imipenem/Cilastatin vs. Microsphere for Knee Osteoarthritis: A Randomized Controlled Trial

Q3 · MEDICINE

Article

Author: Motta-Leal-Filho, Joaquim M ; Lugokeski, Ricardo ; Correa, Mateus Picada ; Mezzomo, Marcio ; Leite, Lucas Ricci

Genicular artery embolization (GAE) has emerged as a treatment option to improve quality of life in patients suffering from moderate-to-severe pain refractory to conservative treatment of knee osteoarthritis, with encouraging results. This paper describes the study protocol of a single-center, double-blind, randomized controlled trial designed to evaluate and compare the safety and efficacy of GAE using imipenem/cilastatin vs. microspheres for the treatment of moderate-to-severe pain associated with knee osteoarthritis. We hypothesized that there will be no difference in safety and efficacy outcomes. The study received ethics approval of the institutional review board with number 4.364.391 / CAAE: 37590820.3.0000.5342 and is registered onto the Registro Brasileiro de Ensaios Clinicos (ReBEC), with number RBR-2h5rwgb. Technical success was defined as embolization of at least 1 feeding artery supplying the hyperemic synovium of the knee joint. Primary outcome: clinical success was defined as improvement in symptoms, 50% reduction in Western Ontario and McMaster Universities Osteoarthritis Index pain scores or an increase of at least 10 points in the Knee Injury and Osteoarthritis Outcome Score from baseline to 3 months of follow-up. Secondary outcome: radiological success was defined as significant improvement in the Whole-Organ Magnetic Resonance Imaging Score for knee synovitis considering the embolized areas at 12 months of follow-up after GAE and a reduction in the analgesia or other conservative therapies for knee pain used by the patient at 3 and 12 months of follow-up. Clinical assessments will be performed before GAE, during GAE and at hospital discharge (for Visual Analog Scale of pain), and at 30 days, 3 months, and 12 months after GAE.

01 Sep 2021·Revista espanola de medicina nuclear e imagen molecular

Radiation exposure of the operators in the preparation and administration of yttrium-90 microspheres in the treatment of malignant hepatic lesions: What is the risk?

Article

Author: Morasca, Andrea ; Scotognella, Teresa ; Iezzi, Roberto ; Perotti, Germano ; Zagaria, Luca ; Giordano, Alessandro ; Indovina, Luca ; Capostosti, Amedeo

Liver radioembolization is an emerging treatment against liver primary and secondary tumours. The whole procedure of radioembolization involves different health care specialists with different expertise. During the fractionation and infusion phases, the personnel manipulates high activities of ⁹⁰Y. In our centre, the number of radioembolization treatments per year is increasing; the aim of this study is to monitor the dose to the operators and to estimate the radiological risk for the operators involved in the RE. At present, two medical devices are approved: Sir-Sphere® and Therasphere™, both loaded with ⁹⁰Y. The dosimeters used were TLDs placed over the fingertips, for a total of 4 dosimeters for each phase; the selected dose descriptor was Hp_0.07. The study concerned 17 patients affected by malignant hepatic lesions, treated from September 2017 to March 2018. We performed 27 procedures: 10 fractionations (with Sir-Sphere®) and 17 infusions to the patients (10 with Sir-Spheres®, 7 with Theraspheres™). For fractionation phase, the average activity of each preparation was 3.34 GBq, the average value of Hp_0.07 was 0.50mSv. For infusion phase, the average activity was 1.51 GBq for Sir-Sphere® and 2.10 GBq for Theraspheres™, the average value of Hp_0.07 was 0.10mSv. No significant differences were found between senior (Hp_0.07 = 0.08mSv) and young operators (Hp_0.07 = 0.09mSv), respectively. Similarly, no significant differences were found between the right and left hand, with the same average value of Hp_0.07 (0.01mSv). In conclusion, the results are encouraging, since fingertips reported doses very low. The handling of ⁹⁰Y microspheres and the radioembolization procedure can be carried out under safe conditions.

News (Medical) associated with SIR-Spheres

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

15 Sep 2022

·www.prnewswire.com

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

Radiation 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	DE	Sirtex Medical Pty Ltd.	22 Mar 2022
Liver Cancer	DE	Sirtex Medical Pty Ltd.	22 Mar 2022
Colorectal Cancer	US	Sirtex Medical Pty Ltd.	03 May 2002
Liver metastases	US	Sirtex Medical Pty Ltd.	03 May 2002

Clinical Result

Indication

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Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03380130 (NASIR-HCC, Pubmed) Manual	Phase 2	Hepatocellular Carcinoma	42	Nivolumab+SIR-Spheres	tfeiojbqja(xhtuybknts) = kgfyzhjfnw hanromdifb (tucidsyvgr ) View more	Positive	01 Nov 2022
NCT02416466 (HITM-SIR, Pubmed \| Cancer Gene Ther) Manual	Phase 1	Liver metastases CEA Positive	4	Anti-CEA CAR-T+SIR-Spheres	bwbvdhsmqz(tgrbyoxnzu) = macaorhbxb mnbuqqxjgl (bmgzheaizp ) View more	Positive	01 May 2020
NCT01482442 (SARAH, Pubmed \| Lancet Oncol) Manual	Phase 3	Locally Advanced Hepatocellular Carcinoma	459	sorafenib+yttrium-90 resin microspheres	aiubzytdpe(rdamwbbaox) = zvardcyhoe khlitnkdou (vqonkdbiex, 6.7 ~ 9.9) View more	Positive	01 Dec 2017
NCT01482442 (SARAH, Pubmed \| Lancet Oncol) Manual	Phase 3	Locally Advanced Hepatocellular Carcinoma	459	sorafenib	aiubzytdpe(rdamwbbaox) = kevlibxlzl khlitnkdou (vqonkdbiex, 8.7-11.4) View more	Positive	01 Dec 2017
NCT01721954 \| ISRCTN83867919 \| NCT00724503 (SIRFLOX \| FOXFIRE-Global \| FOXFIRE, Pubmed) Manual	Phase 3	Colorectal Cancer First line	1,103	oxaliplatin+fluorouracil+leucovorin+SIRT	dehwqnjskk(oihqolsoog) = xwmdmbodqa eoxjndylll (ibgufkcnqm ) View more	Non-superior	01 Sep 2017
	Phase 3	Colorectal Cancer First line	1,103	leucovorin+fluorouracil+oxaliplatin	dehwqnjskk(oihqolsoog) = iaobxcagol eoxjndylll (ibgufkcnqm ) View more	Non-superior	01 Sep 2017
NCT00724503 (SIRFLOX, Pubmed \| J Urol) Manual	Phase 3	Colorectal Cancer First line	530	fluorouracil+leucovorin+oxaliplatin+Bevacizumab+yttrium-90	quoadwgzja(bhztiosyma) = ivqwycsegs eppvednkvh (ytavtzzubl ) View more	Similar	20 May 2016
NCT00724503 (SIRFLOX, Pubmed \| J Urol) Manual	Phase 3	Colorectal Cancer First line	530	fluorouracil+leucovorin+oxaliplatin+Bevacizumab	quoadwgzja(bhztiosyma) = wpbapjrgyo eppvednkvh (ytavtzzubl ) View more	Similar	20 May 2016
ASCO2008	Not Applicable	Liver metastases	34	Radioactive microspheres (Yttrium-90 resin microspheres)	mjoctjocat(wisfencids) = mild to severe bgnseiklay (jjazdkkgjt )	-	20 May 2008
ASCO2004	Not Applicable	Unresectable Hepatocellular Carcinoma	80	90Yttrium microspheres (Therasphere)	htnasitphr(wptdwnldzf) = mtatsqwynj noxrhuzdrc (jiramuhlzh ) View more	-	15 Jul 2004

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