Back to resultsPreoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis
Primary Purpose
Colorectal Cancer, Liver Metastases
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Trans arterial chemoembolization with Irinotecan Drug-eluting Beads
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Zhongshan Hospital Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm A
Arm B
Arm Description
DEB-TACE before liver surgery
direct liver surgery
Outcomes
Primary Outcome Measures
liver relapse-free survival
from liver surgery to liver relapse
Secondary Outcome Measures
relapse-free survival
overall survival
response rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04912258
Brief Title
Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis
Official Title
Trans-arterial Chemoembolization With Irinotecan Drug-eluting Beads Before Liver Surgery for Patients With Primary Unresectable Colorectal Liver Metastasis: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Liver Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
DEB-TACE before liver surgery
Arm Title
Arm B
Arm Type
No Intervention
Arm Description
direct liver surgery
Intervention Type
Drug
Intervention Name(s)
Trans arterial chemoembolization with Irinotecan Drug-eluting Beads
Other Intervention Name(s)
Irinotecan Drug-eluting Beads
Intervention Description
preoperative chemoembolization with Irinotecan Drug-eluting Beads
Primary Outcome Measure Information:
Title
liver relapse-free survival
Description
from liver surgery to liver relapse
Time Frame
6 months
Secondary Outcome Measure Information:
Title
relapse-free survival
Time Frame
6 months
Title
overall survival
Time Frame
12 months
Title
response rate
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Xu
Phone
+8613501984869
Ext
+8613501984869
Email
xujmin@aiiyun.com
Facility Information:
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu
Phone
18834823867
Ext
18834823867
Email
13301050195@fudan.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis
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