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

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT03175016
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Colon Cancer Liver Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TACE — PROCEDURE
    Transcatheter arterial chemoembolization（TACE）is a minimally invasive procedure performed to restrict a tumor's blood supply.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 20, 2017
Status verified
May 2017
Primary completion
Aug 31, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DEBIRI
    Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI)

Primary Outcome Measure

Tumor Response of two months [ Time Frame: Two months post first treatment ]

Central Contacts

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