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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEBIRI | Experimental | Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE | Procedure | Transcatheter arterial chemoembolization(TACE)is a minimally invasive procedure performed to restrict a tumor's blood supply. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response of two months | Response rate(RR) | Two months post first treatment |
| Tumor Response of four months | Response rate(RR) | four months post first treatment |
| Tumor Response of six months | Response rate(RR) | Six months post first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | overall survival(OS) | From date of first treatment until the date of death from any cause, whichever came first, assessed up to 24 months |
| Time to intrahepatic progression | Time to intrahepatic progression(THP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi Guo, PhD | Contact | 13920076145 | cjr.guozhi@vip.163.com | |
| Xueling Yang, PhD | Contact | 15620930669 | yxueling123@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Irinotecan | Drug | Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in eluting-beads and injected in the tumor. |
|
| eluting-bead | Device | The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer. |
|
| From date of first treatment until the date of intrahepatic progression, whichever came first, assessed up to 24 months |
| Time to extrahepatic progression | Time to extrahepatic progression(TEP) | From date of first treatment until the date of extrahepatic progression, whichever came first, assessed up to 24 months |
| Quality of life | Assesment Quality of life by EORTC QOL-C30 questionnaire | Six months post first treatment |