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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Transcatheter arterial chemoembolization(TACE)is a minimally invasive procedure performed to restrict a tumor's blood supply.
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.
The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGTumor Response of two months
Response rate(RR)
Time frame: Two months post first treatment
Tumor Response of four months
Response rate(RR)
Time frame: four months post first treatment
Tumor Response of six months
Response rate(RR)
Time frame: Six months post first treatment
overall survival
overall survival(OS)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Six months post first treatment
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