{"id":"sir-sphere","safety":{"commonSideEffects":[{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Radiation-induced liver disease"},{"rate":null,"effect":"Elevated liver enzymes"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"SIR-Sphere consists of biocompatible resin microspheres loaded with yttrium-90, a beta-emitting radioisotope. When injected into the hepatic artery, the microspheres lodge in the tumor vasculature and deliver localized radiation therapy to hepatocellular carcinoma and liver metastases while minimizing systemic exposure.","oneSentence":"SIR-Sphere delivers yttrium-90 radiation directly to liver tumors via microspheres injected into the hepatic artery.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:34:45.242Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hepatocellular carcinoma"},{"name":"Liver metastases"}]},"trialDetails":[{"nctId":"NCT04903548","phase":"","title":"Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC With Y90 SIR-Spheres","status":"COMPLETED","sponsor":"Methodist Health System","startDate":"2021-01-08","conditions":"Hepatocellular Carcinoma","enrollment":1},{"nctId":"NCT03028311","phase":"PHASE1","title":"Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2017-01-09","conditions":"Metastatic Liver Carcinoma, Stage IV Liver Cancer, Stage IVA Liver Cancer","enrollment":12},{"nctId":"NCT03256994","phase":"","title":"CIRSE Registry for SIR-Spheres in France (CIRT-FR)","status":"COMPLETED","sponsor":"Cardiovascular and Interventional Radiological Society of Europe","startDate":"2017-08-01","conditions":"Liver Cancer","enrollment":332},{"nctId":"NCT04736121","phase":"NA","title":"Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sirtex Medical","startDate":"2021-05-28","conditions":"Unresectable Hepatocellular Carcinoma, BCLC Stage A Hepatocellular Carcinoma, BCLC Stage B Hepatocellular Carcinoma","enrollment":100},{"nctId":"NCT06860815","phase":"PHASE2","title":"Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2026-04-01","conditions":"Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Carcinoma in the Liver","enrollment":11},{"nctId":"NCT07293468","phase":"PHASE2, PHASE3","title":"Comparison of SBRT and SIRT With Combination IO for Locally-advanced, Unresectable HCCs (BIIRTH)","status":"RECRUITING","sponsor":"Tuen Mun Hospital","startDate":"2024-04-01","conditions":"Hepatocellular Carcinoma (HCC)","enrollment":106},{"nctId":"NCT01473004","phase":"PHASE2","title":"SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver","status":"COMPLETED","sponsor":"Thomas Jefferson University","startDate":"2011-10-31","conditions":"Stage IV Uveal Melanoma","enrollment":48},{"nctId":"NCT05377034","phase":"PHASE2","title":"Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab, vs SIRT (SIRT-Y90) Followed by Placebo in Locally Advanced HCC Patients","status":"RECRUITING","sponsor":"National Cancer Centre, Singapore","startDate":"2022-10-26","conditions":"Locally Advanced Hepatocellular Carcinoma","enrollment":100},{"nctId":"NCT04605731","phase":"PHASE1","title":"Durvalumab and Tremelimumab After Radioembolization for the Treatment of Unresectable, Locally Advanced Liver Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2021-08-03","conditions":"BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, Locally Advanced Hepatocellular Carcinoma","enrollment":25},{"nctId":"NCT05701488","phase":"PHASE1","title":"SIRT With Tremelimumab and Durvalumab for Resectable HCC","status":"RECRUITING","sponsor":"Jiping Wang, MD, PhD","startDate":"2023-04-21","conditions":"Resectable Hepatocellular Carcinoma, Hepatocellular Carcinoma, Hepatocellular Cancer","enrollment":20},{"nctId":"NCT02807181","phase":"PHASE2, PHASE3","title":"SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma","status":"TERMINATED","sponsor":"Sirtex Medical","startDate":"2017-02-14","conditions":"Intrahepatic Cholangiocarcinoma","enrollment":89},{"nctId":"NCT05848947","phase":"PHASE4","title":"SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA","status":"COMPLETED","sponsor":"Sirtex Medical","startDate":"2023-04-25","conditions":"Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasm","enrollment":5},{"nctId":"NCT02936388","phase":"PHASE2","title":"Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis","status":"COMPLETED","sponsor":"Charite University, Berlin, Germany","startDate":"2016-01","conditions":"Uveal Melanoma","enrollment":108},{"nctId":"NCT06178198","phase":"PHASE2","title":"Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma","status":"RECRUITING","sponsor":"Seoul National University Hospital","startDate":"2023-11-08","conditions":"Hepatocellular Carcinoma","enrollment":30},{"nctId":"NCT06712017","phase":"","title":"Observational Study for SIR-Spheres Therapy for the Treatment of HCC Patients in China","status":"ENROLLING_BY_INVITATION","sponsor":"GrandPharma (China) Co., Ltd.","startDate":"2024-08-22","conditions":"Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma Non-Resectable","enrollment":100},{"nctId":"NCT05967143","phase":"","title":"Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)","status":"RECRUITING","sponsor":"Sirtex Medical","startDate":"2023-06-19","conditions":"Unresectable Hepatocellular Carcinoma (HCC), Liver Metastases From Colorectal Cancer (mCRC)","enrollment":845},{"nctId":"NCT02512692","phase":"NA","title":"Gemcitabine-Cisplatin-90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma","status":"TERMINATED","sponsor":"Medical University of South Carolina","startDate":"2015-07-21","conditions":"Intrahepatic Cholangiocarcinoma","enrollment":6},{"nctId":"NCT05315687","phase":"PHASE2","title":"Radioembolization of Metastatic Breast Cancer to the Liver as a 2nd/3rd Line Therapy","status":"WITHDRAWN","sponsor":"Emory University","startDate":"2022-08-17","conditions":"Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Carcinoma in the Liver","enrollment":""},{"nctId":"NCT02859064","phase":"PHASE2","title":"Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres","status":"TERMINATED","sponsor":"SCRI Development Innovations, LLC","startDate":"2017-07-28","conditions":"Neuroendocrine Tumors, Gastrointestinal Neoplasms, Carcinoid Tumors","enrollment":6},{"nctId":"NCT02195011","phase":"PHASE2","title":"Safety Study of Regorafenib and SIR-Spheres® Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases","status":"COMPLETED","sponsor":"SCRI Development Innovations, LLC","startDate":"2014-07","conditions":"Colorectal Neoplasms","enrollment":26},{"nctId":"NCT06079242","phase":"","title":"Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer","status":"NOT_YET_RECRUITING","sponsor":"GrandPharma (China) Co., Ltd.","startDate":"2023-10-15","conditions":"Colorectal Neoplasms","enrollment":200},{"nctId":"NCT04172714","phase":"NA","title":"Low-dose Y90 Treatment Planning for HCC","status":"COMPLETED","sponsor":"Emory University","startDate":"2019-12-16","conditions":"HCC, Cancer of Liver, Cancer","enrollment":30},{"nctId":"NCT02602327","phase":"PHASE1","title":"Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2017-01-09","conditions":"Colon Cancer, Rectal Cancer, Liver Metastases","enrollment":21},{"nctId":"NCT03912844","phase":"","title":"European SIR-Spheres Surgical Registry","status":"UNKNOWN","sponsor":"Universitätsklinikum Köln","startDate":"2019-07-25","conditions":"Hepatectomy","enrollment":250},{"nctId":"NCT02685631","phase":"","title":"Yttrium Y 90 Resin Microspheres Data Collection in Unresectable Liver Cancer: the RESIN Study","status":"COMPLETED","sponsor":"Vanderbilt-Ingram Cancer Center","startDate":"2015-07","conditions":"Localized Non-Resectable Adult Liver Carcinoma","enrollment":1653},{"nctId":"NCT02913417","phase":"PHASE1, PHASE2","title":"Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver Metastases","status":"UNKNOWN","sponsor":"David Minor, MD","startDate":"2016-10-10","conditions":"Uveal Melanoma, Hepatic Metastases","enrollment":26},{"nctId":"NCT00503867","phase":"NA","title":"SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma","status":"TERMINATED","sponsor":"Sirtex Medical","startDate":"2007-07-18","conditions":"Carcinoma, Hepatocellular, Hepatoma","enrollment":10},{"nctId":"NCT03380130","phase":"PHASE2","title":"A Study of the Safety and Antitumoral Efficacy of Nivolumab After SIRT for the Treatment of Patients With HCC","status":"COMPLETED","sponsor":"Clinica Universidad de Navarra, Universidad de Navarra","startDate":"2017-09-11","conditions":"Hepatocellular Carcinoma","enrollment":41},{"nctId":"NCT02305459","phase":"","title":"CIRSE Registry for SIR-Spheres Therapy","status":"COMPLETED","sponsor":"Cardiovascular and Interventional Radiological Society of Europe","startDate":"2014-11","conditions":"Liver Carcinoma","enrollment":1051},{"nctId":"NCT02288507","phase":"PHASE1","title":"Sorafenib Concurrent With Yttrium-90 Transarterial Radioembolization in Patients With Advanced Hepatocellular Cancer","status":"WITHDRAWN","sponsor":"University of Hawaii","startDate":"2014-11","conditions":"Hepatocellular Cancer","enrollment":""},{"nctId":"NCT01721954","phase":"PHASE3","title":"FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer","status":"COMPLETED","sponsor":"Sirtex Medical","startDate":"2013-05-01","conditions":"Colorectal Cancer Metastatic","enrollment":209},{"nctId":"NCT01126645","phase":"PHASE2","title":"Sorafenib and Micro-therapy Guided by Primovist Enhanced MRI in Patients With Inoperable Liver Cancer","status":"COMPLETED","sponsor":"University of Magdeburg","startDate":"2010-12","conditions":"Hepatocellular Carcinoma","enrollment":529},{"nctId":"NCT02416466","phase":"PHASE1","title":"CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases","status":"COMPLETED","sponsor":"Roger Williams Medical Center","startDate":"2015-04","conditions":"Liver Metastases","enrollment":8},{"nctId":"NCT00724503","phase":"NA","title":"FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer","status":"COMPLETED","sponsor":"Sirtex Medical","startDate":"2006-08","conditions":"Colorectal Cancer, Colorectal Carcinoma, Liver Metastases","enrollment":530},{"nctId":"NCT01469572","phase":"PHASE1","title":"Pasireotide, Everolimus and Selective Internal Radioembolization Therapy for Unresectable Hepatic Metastases","status":"COMPLETED","sponsor":"Emory University","startDate":"2011-12","conditions":"Neuroendocrine Tumors","enrollment":13},{"nctId":"NCT03686709","phase":"NA","title":"Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment","status":"RECRUITING","sponsor":"University of Tennessee","startDate":"2018-06-19","conditions":"Hepatocellular Carcinoma, Radiation Exposure","enrollment":20},{"nctId":"NCT01135056","phase":"PHASE3","title":"Study to Compare Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced Hepatocellular Carcinoma (HCC)","status":"UNKNOWN","sponsor":"Singapore General Hospital","startDate":"2010-07","conditions":"Hepatocellular Carcinoma","enrollment":360},{"nctId":"NCT01893099","phase":"PHASE1","title":"Sorafenib and Radioembolization With Sir-Spheres® for the Treatment of Metastatic Ocular Melanoma","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire Vaudois","startDate":"2013-06","conditions":"Ocular Melanoma","enrollment":11},{"nctId":"NCT03292991","phase":"","title":"REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)","status":"UNKNOWN","sponsor":"Taipei Veterans General Hospital, Taiwan","startDate":"2015-06-09","conditions":"Hepatocellular Carcinoma","enrollment":100},{"nctId":"NCT01895257","phase":"PHASE3","title":"Comparing HAI-90Y (SIR-spheres)+Chemotx LV5FU2 Versus Chemotx LV5FU2 Alone to Treat Colorectal Cancer","status":"UNKNOWN","sponsor":"Universiteit Antwerpen","startDate":"2013-08","conditions":"Colorectal Cancer","enrollment":162},{"nctId":"NCT01798147","phase":"PHASE2","title":"Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).","status":"UNKNOWN","sponsor":"Johannes Gutenberg University Mainz","startDate":"2011-02","conditions":"Intrahepatic Cholangiocellular Carcinoma","enrollment":24},{"nctId":"NCT03117855","phase":"PHASE1","title":"Capecitabine and Y-90 Radioembolization in Treating Patients With Advanced Bile Duct Cancer in the Liver That Cannot Be Removed by Surgery","status":"WITHDRAWN","sponsor":"City of Hope Medical Center","startDate":"2016-12","conditions":"Bile Duct Adenocarcinoma, Stage III Intrahepatic Cholangiocarcinoma, Stage IVA Intrahepatic Cholangiocarcinoma","enrollment":""},{"nctId":"NCT01482442","phase":"PHASE3","title":"SorAfenib Versus RADIOEMBOLIZATION in Advanced Hepatocellular Carcinoma","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2011-12","conditions":"Liver Carcinoma","enrollment":496},{"nctId":"NCT00712790","phase":"PHASE1, PHASE2","title":"Study of SIR-Spheres Plus Sorafenib as 1st Line Treatment for Non-resectable Primary Hepatocellular Carcinoma (HCC)","status":"COMPLETED","sponsor":"Singapore Clinical Research Institute","startDate":"2008-06","conditions":"Hepatocellular Carcinoma","enrollment":35},{"nctId":"NCT01798160","phase":"PHASE4","title":"Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).","status":"COMPLETED","sponsor":"Johannes Gutenberg University Mainz","startDate":"2010-02","conditions":"Hepatocellular Carcinoma","enrollment":24},{"nctId":"NCT00604409","phase":"PHASE1","title":"Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer","status":"COMPLETED","sponsor":"Fox Chase Cancer Center","startDate":"2006-04","conditions":"Metastatic Liver Cancer","enrollment":34},{"nctId":"NCT00735241","phase":"PHASE2, PHASE3","title":"FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma","status":"WITHDRAWN","sponsor":"Sirtex Medical","startDate":"2008-07","conditions":"Colorectal Carcinoma, Liver Metastases","enrollment":""},{"nctId":"NCT00972036","phase":"PHASE1","title":"Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2009-08","conditions":"Colon Cancer, Rectal Cancer","enrollment":32},{"nctId":"NCT01186263","phase":"PHASE2","title":"Predictive Value of 99mTc- Albumin Spheres Before 90Y- SIR Therapy","status":"COMPLETED","sponsor":"University of Magdeburg","startDate":"2010-07","conditions":"Colorectal Cancer, Liver Metastases","enrollment":24},{"nctId":"NCT01898962","phase":"PHASE2","title":"Definitive Therapy for Oligometastatic Solid Malignancies","status":"UNKNOWN","sponsor":"Rocky Mountain Cancer Centers","startDate":"2005-12","conditions":"Stage IV or Recurrent Carcinoma or Sarcoma","enrollment":110},{"nctId":"NCT01432119","phase":"PHASE1","title":"Phase 1 Trial With SIR-Spheres and Cetuximab +/- Erlotinib","status":"WITHDRAWN","sponsor":"M.D. Anderson Cancer Center","startDate":"2012-12","conditions":"Advanced Cancers","enrollment":""},{"nctId":"NCT00766220","phase":"PHASE2","title":"Yttrium Microspheres With Cetuximab Plus Irinotecan for Patients With Advanced Colorectal Cancer Mets to Liver","status":"WITHDRAWN","sponsor":"M.D. Anderson Cancer Center","startDate":"2009-10","conditions":"Colon Cancer, Colorectal Cancer","enrollment":""},{"nctId":"NCT00469963","phase":"NA","title":"Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery","status":"TERMINATED","sponsor":"Vanderbilt-Ingram Cancer Center","startDate":"2003-12","conditions":"Liver Cancer","enrollment":12},{"nctId":"NCT00466856","phase":"PHASE2","title":"Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors","status":"TERMINATED","sponsor":"Vanderbilt-Ingram Cancer Center","startDate":"2003-12","conditions":"Head and Neck Cancer, Islet Cell Tumor, Metastatic Cancer","enrollment":10},{"nctId":"NCT00867750","phase":"PHASE2","title":"SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma","status":"COMPLETED","sponsor":"Sirtex Medical","startDate":"2006-03","conditions":"Hepatocellular Carcinoma","enrollment":28},{"nctId":"NCT00891800","phase":"PHASE2","title":"Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver","status":"TERMINATED","sponsor":"St. Joseph's Hospital, Florida","startDate":"2007-07","conditions":"Breast Cancer Metastatic to the Liver","enrollment":50},{"nctId":"NCT00199173","phase":"PHASE3","title":"Comparing Hepatic Intra-arterial Injection of Yttrium-90 Microspheres Versus Fluorouracil (5FU) in Colorectal Cancer Metastatic to the Liver Only","status":"COMPLETED","sponsor":"Jules Bordet Institute","startDate":"","conditions":"Colorectal Neoplasm, Secondary Malignant Neoplasm of Liver","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":15,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"SIR-Sphere","genericName":"SIR-Sphere","companyName":"Assistance Publique - Hôpitaux de Paris","companyId":"assistance-publique-h-pitaux-de-paris","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SIR-Sphere delivers yttrium-90 radiation directly to liver tumors via microspheres injected into the hepatic artery. Used for Hepatocellular carcinoma, Liver metastases.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}