Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer
DEBIRI-CRLM
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedStudy Start
First participant enrolled
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJune 27, 2017
May 1, 2017
2.1 years
May 28, 2017
June 25, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (4)
overall survival
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
From date of first treatment until the date of intrahepatic progression, whichever came first, assessed up to 24 months
Time to extrahepatic progression
From date of first treatment until the date of extrahepatic progression, whichever came first, assessed up to 24 months
Quality of life
Six months post first treatment
Study Arms (1)
DEBIRI
EXPERIMENTALTranscatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.
- Patients with primary colorectal lesions removed, and negative extrahepatic metastasis
- Patients with at least one measurable liver metastases, with size \> 2cm or less than 5 liver metastases,with size smaller than 10cm.
- Patients have received at least six cycle system chemotherapy based irinotecan or oxaliplatin and got a failure outcome; or patients who are intolerance of operation.
- No intervention therapy was received for liver lesions during one year.
- Life expectancy of \> 3 months
- Child-pugh's grade A or B (no more than 7 score).
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of \< 2
- Signed, written informed consent
You may not qualify if:
- Patients with extrahepatic metastasis
- Patients has received TACE,ablation and iodine seed implantation for liver lesions during one year.
- With obvious arterio-venous fistula
- Patients suffered with other cancer(Except for cured basal or squamous cell skin cancer or cervical carcinoma in situ)
- Hematologic function: leukocytes \<3000cell/mm3, platelets\<50000/mm3, with no hypersplenism.
- Adequate renal function (creatinine ≤ 2.0mg/dl)
- Alanine transaminase(ALT) and/or glutamic oxalacetic transaminase(AST) \>5 times upper limit of normal(ULN)
- International Normalized Ratio (INR) \>1.5, or being treated by anticoagulants, or being suffered hemorrhagic disease.
- With serious heart, kidney, bone marrow, or lung, central nervous system diseases.
- With recent infections and received antibiotics.
- Other conditions place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2017
First Posted
June 5, 2017
Study Start
June 20, 2017
Primary Completion
August 1, 2019
Study Completion
December 1, 2019
Last Updated
June 27, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share