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Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer

ABSTRACT: This is a multicentre, open labeled, single arm study to determine effectiveness and safety of chemoembolization with Irinotecan-Eluting Bead(DEBIRI) in the treatment of unresectable liver metastases in patients with colorectal cancer after chemotherapy failure.

DISEASE(S): Neoplasm Metastasis,Colon Cancer Liver Metastasis,Liver Neoplasms

PROVIDER: 2246057 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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DEBIRI

Project description:Interventions: Hepatic Arterial Chemoembolization using drug-eluting beads loaded with irinotecan (DEBIRI) for Refractory Colorectal Cancer with Liver Metastases.;Colorectal cancer, Liver metastasis, DEBIRI Primary outcome(s): liver-specific progression-free survival Study Design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose

| 2615389 | ecrin-mdr-crc

Irinotecan -Eluting LC Bead-M1 (DEBIRI-M1) for Patients With Liver Metastases From Colorectal Cancer

Project description:Purpose: The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with liver lesions from colorectal cancer. The beads (LC-Bead M1) will be loaded with irinotecan (DEBIRI-M1), and used to administer transarterial chemoembolization (TACE). Eligibility: Patients with liver cancer from colorectal cancer. Study Overview/ Treatment: DEBIRI, loaded with irinotecan, is a device that utilizes tiny beads (70-150 microns) to deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows for continuous release of irinotecan into the liver tumor tissue(s) causing necrosis of the targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and blood tests (to include assessment of liver function and tumor markers) and by imaging (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will be exited from the study and followed for survival. Once exited from the study they will continue to be eligible to receive DEBIRI, should it be recommended.

| 2157209 | ecrin-mdr-crc

Irinotecan Drug-eluting Bead Liver Embolisation Registry

Project description:Purpose: The purpose of this study is: to assess and define the current practice of the delivery of irinotecan loaded drug eluting beads in the treatment of liver metastases from colorectal cancer; to correlate how the delivery of this drug compares to worldwide/European guidelines, and to determine which individual variations in delivery may be associated with an increased complication profile or better outcome. The aim of the study is to: 1. Prospectively evaluate the number of centres providing DEBIRI 2. To determine the number of patients being treated nationally per year 3. To evaluate individual variations in practice with respect to number of treatments, method of pain control, side effect profile, and complication profile. 4. To collect patient specific data subsets to allow correlation and causal associations between these individual variations, and relate these to efficacy and survival during the study period.

| 2286129 | ecrin-mdr-crc

To Evaluate the Performance of HepaSphere Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy on Unresectable Colorectal Liver Metastases

Project description:Both drug-eluting bead transarterial chemoembolization (DEB-TACE) and hepatic arterial infusion chemotherapy (HAIC) are recommended for unresectable colorectal liver metastases (CRLM) treatment. However, the combined application of DEB-TACE and HAIC is not widely accepted. The aim of this single-center retrospective study was to evaluate the efficacy and safety of Irinotecan-eluting HepaSphere chemoembolization combined with HAIC for unresectable CRLM

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Gene expression response to implanted drug (paclitaxel)-eluting or bare metal stents in denuded human LIMA arteries

2010-03-01 | GSE19136 | GEO

Inflammation and Extracellular Matrix Genes Differentially Expressed Following Overlapping Zotarolimus- and Sirolimus-Eluting Stent Implantation

2011-04-22 | GSE28781 | GEO

Inflammation and Extracellular Matrix Genes Differentially Expressed Following Overlapping Zotarolimus- and Sirolimus-Eluting Stent Implantation

Project description:An unanticipated complication of the use of bare metal stents in percutaneous transluminal coronary angioplasty is in-stent restenosis resulting in >50% late lumen diameter loss in treated patients. In an effort to reduce in-stent restenosis, drug eluting stents containing the immunosuppressant sirolimus or zotarolimus have recently been developed. We report here the molecular response of arterial tissue to the implanting of these drug-eluting stents. Gene expression profiling was performed on 4 artery segments surrounding bare metal stents (BMS), 4 artery segments surrounding sirolimus-eluting stents (SES), and 4 artery segments surrounding zotarolimus-eluting stents (ZES) implanted into porcine animal models for 28 days.

2011-04-22 | E-GEOD-28781 | biostudies-arrayexpress

Gene expression response to implanted drug (paclitaxel)-eluting or bare metal stents in denuded human LIMA arteries

Project description:[original title] Gene expression response to the implantation of drug (paclitaxel)-eluting or bare metal stents in denuded human LIMA arteries. Different clinical outcomes have been observed for paclitaxel-eluting and bare metal cardiovascular stents. The aim of this project was to identify genes that might be associated with the observed clinical outcomes. Human left internal mammary artery (LIMA) was divided into three segments and and two of the segments were fitted with either a paclitaxel-eluting stent or a bare metal stent. The experiment includes three groups: control, paclitaxel-eluting stent, and bare metal stent, respectively. Each group includes four biological replicates (patients 1, 2, 4 and 5).

2010-03-07 | E-GEOD-19136 | biostudies-arrayexpress

Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis

Project description:Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis

| 2379485 | ecrin-mdr-crc

Gene expression pattern after insertion of dexamethasone-eluting electrode into the guinea pig cochlea.

Project description:To investigate the effect of the dexamethasone-eluting electrode in the guinea pig cochlea, and compared the gene expression after 7 days insertion with that of a normal electrode or non-treated control by microarray.

2014-01-17 | GSE53866 | GEO

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