Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis
Trans-arterial Chemoembolization With Irinotecan Drug-eluting Beads Before Liver Surgery for Patients With Primary Unresectable Colorectal Liver Metastasis: A Randomized Control Trial
1 other identifier
interventional
80
1 country
1
Brief Summary
Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 colorectal-cancer
Started Aug 2021
Shorter than P25 for phase_3 colorectal-cancer
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
June 2, 2021
CompletedFirst Posted
Study publicly available on registry
June 3, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 3, 2021
March 1, 2021
1.3 years
June 2, 2021
June 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
liver relapse-free survival
from liver surgery to liver relapse
6 months
Secondary Outcomes (3)
relapse-free survival
6 months
overall survival
12 months
response rate
2 months
Study Arms (2)
Arm A
EXPERIMENTALDEB-TACE before liver surgery
Arm B
NO INTERVENTIONdirect liver surgery
Interventions
preoperative chemoembolization with Irinotecan Drug-eluting Beads
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years;
- Histologically proven colorectal liver metastasis；
- With liver-dominant disease；
- Primarily evaluated as potentially resectable and conversed successfully
- Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3 (within 1 week prior to randomization)
- Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl (within 1 week prior to randomization);
- Written informed consent for participation in the trial.
You may not qualify if:
- Primarily evaluated as resectable
- Failed to converse
- Patients with known hypersensitivity reactions to any of the components of the study treatments.
- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- Other previous malignancy within 5 years
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2021
First Posted
June 3, 2021
Study Start
August 1, 2021
Primary Completion
December 1, 2022
Study Completion
June 1, 2023
Last Updated
June 3, 2021
Record last verified: 2021-03