Embozene TANDEM 微球（CE）
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校准
严格校准，以适用于更多栓塞选择
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药物装载
在药物装载和储存过程中，微球大小保持稳定;典型尺寸变化小于 5%
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高效药物装载
30-120 分钟，取决于具体药物
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每毫升微球最多可装载 50 mg 药物：
- 盐酸多柔比星粉剂或溶液
- 盐酸伊立替康
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3 种粒径微球 x 2 ml/3 ml 注射器
40 μm 至 100 μm
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自制造之日起保质期为 3 年
自制造之日起
CE 认证国家
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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 | DEB-TACE with Doxorubicin | HCC | 25 | Freedom From: | Safety (30D, 6M), Tumor progression (6M) Time to progression, Local tumor control, Survival (12M) |
Mauri et al, 2018² | DEB-TACE with Irinotecan | mCRC | 18 | 30 Day SAE-Free: 100% (18/18) | 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.
Randomized Controlled Trials Evaluating Doxorubicin-TACE for Treatment of HCC
- 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.
Randomized Controlled Trials Evaluating Irinotecan-TACE for Treatment of mCRC
- 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.
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CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France.
