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Embozene TANDEM 微球（CE）
精准、灵活、可控。
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1
校准
严格校准，以适用于更多栓塞选择
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2
药物装载
药物装载不影响微球粒径，微球粒径变化 < 5%
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3
高效药物装载
30-120 分钟，取决于具体药物
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4
每毫升微球最多可装载 50 mg 药物：
- 盐酸多柔比星粉末或溶液 - 盐酸伊立替康
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5
3 种粒径微球 x 2 ml/3 ml 注射器
40 μm 至 100 μm
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6
自制造之日起保质期为 3 年
自制造之日起
参考文献
评估 TANDEM 和多柔比星或伊立替康的临床试验
| Publication / Study | Treatment | Disease State & Staging | Number of Patients | Results | Endpoints (*=Primary) |
|---|---|---|---|---|---|
| Richter et al, 2018¹ MIRACLE I |
DEB-TACE with Doxorubicin | HCC ECOG: 0-2 Child-Pugh: A or B* |
25 | Freedom From: 30D SAEs: 92% 6M SAEs: 71% 6M tumor progression: 76% Tumor control: 95% 12M Survival: 56% (w/o ascites 73%) |
Safety (30D, 6M), Tumor progression (6M) Time to progression, Local tumor control, Survival (12M) |
| Mauri et al, 2018² MIRACLE III |
DEB-TACE with Irinotecan | mCRC ECOG: 0-1** |
18 | 30 Day SAE-Free: 100% (18/18) 3M Tumor Control: 88.9% (17/18) 6M Tumor Control: 41.2% (7/17) 12M Tumor Control: 17.6% (3/17) 12M Survival: 44% |
Safety (30D), Tumor control (3M), Secondary: Tumor control (6M, 12M), Survival (12M) |
- *One study patient 1/25 (4%) treated was Child-Pugh C.
- **All study patients 18/18 (100%) treated were ECOG 0.
- 1 Richter, G., et al., Safety and Feasibility of Chemoembolization with Doxorubicin-Loaded Small Calibrated Microspheres in Patients with Hepatocellular Carcinoma: Results of the MIRACLE I Prospective Multicenter Study. Cardiovasc Intervent Radiol (2018) 41:587–593
- 2 Mauri, G., et al., Transarterial Embolization with Small-Size Particles Loaded with Irinotecan for the Treatment of Colorectal Liver Metastases: Results of the MIRACLE III Study. Cardiovasc Intervent Radiol (2018) 41:1708–1715.
评估使用多柔比星-TACE 治疗肝细胞癌的随机对照试验
- Kawai, S., et al., Prospective and randomized clinical trial for the treatment of hepatocellular carcinoma--a comparison of lipiodol-transcatheter arterial embolization with and without adriamycin (first cooperative study). The Cooperative Study Group for Liver Cancer Treatment of Japan. Cancer Chemother Pharmacol, 1992. 31 Suppl: p. S1-6.
- Llovet, J.M., et al., Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet, 2002. 359(9319): p. 1734-9.
- Brown, K.T., et al., Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone. J Clin Oncol, 2016. 34(17): p. 2046-53.
- Malagari, K., et al., Prospective randomized comparison of chemoembolization with doxorubicin-eluting beads and bland embolization with BeadBlock for hepatocellular carcinoma. Cardiovasc Intervent Radiol, 2010. 33(3): p. 541-51.
- Mabed, M., et al., A randomized controlled trial of transcatheter arterial chemoembolization with lipiodol, doxorubicin and cisplatin versus intravenous doxorubicin for patients with unresectable hepatocellular carcinoma. Eur J Cancer Care (Engl), 2009. 18(5): p. 492-9.
- Lammer, J., et al., Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol, 2010. 33(1): p. 41-52.
- van Malenstein, H., et al., A randomized phase II study of drug-eluting beads versus transarterial chemoembolization for unresectable hepatocellular carcinoma. Onkologie, 2011. 34(7): p. 368-76.
- Sacco, R., et al., Conventional versus doxorubicin-eluting bead transarterial chemoembolization for hepatocellular carcinoma. J Vasc Interv Radiol, 2011. 22(11): p. 1545-52.
- Golfieri, R., et al., Randomised controlled trial of doxorubicin-eluting beads vs conventional chemoembolisation for hepatocellular carcinoma. British Journal of Cancer, 2014. 111(2): p. 255-264.
评估使用伊立替康-TACE 治疗结直肠肿瘤转移的随机对照试验
- Fiorentini, G., et al., Intra-arterial infusion of irinotecan-loaded drug-eluting beads (DEBIRI) versus intravenous therapy (FOLFIRI) for hepatic metastases from colorectal cancer: final results of a phase III study. Anticancer Res, 2012. 32(4): p. 1387-95.
- Martin, R.C., 2nd, et al., Irinotecan drug-eluting beads in the treatment of chemo-naive unresectable colorectal liver metastasis with concomitant systemic fluorouracil and oxaliplatin: results of pharmacokinetics and phase I trial. J Gastrointest Surg, 2012. 16(8): p. 1531-8.
- Martin, R.C., 2nd, et al., Randomized controlled trial of irinotecan drug-eluting beads with simultaneous FOLFOX and bevacizumab for patients with unresectable colorectal liver-limited metastasis. Cancer, 2015. 121(20): p. 3649-58.
参考文献
注意：法律限制这些设备由医生或根据医生的命令销售。适应症、禁忌症、警告和使用说明附在每个设备的产品标签。使用信息仅限具有适用卫生机构注册的国家/地区。该材料不适合在法国使用。
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