Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer
NCT03175016 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2017-06-27
Summary
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.
Conditions
- Colon Cancer Liver Metastasis
Interventions
- PROCEDURE
-
TACE
Transcatheter arterial chemoembolization(TACE)is a minimally invasive procedure performed to restrict a tumor's blood supply.
- 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.
- DEVICE
-
eluting-bead
The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.
Sponsors & Collaborators
-
Tianjin Medical University Cancer Institute and Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-20
- Primary Completion
- 2019-08-31
- Completion
- 2019-12-31
Countries
- China
Study Locations
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