Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis
NCT ID: NCT04912258
Last Updated: 2021-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2021-08-01
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm A
DEB-TACE before liver surgery
Trans arterial chemoembolization with Irinotecan Drug-eluting Beads
preoperative chemoembolization with Irinotecan Drug-eluting Beads
Arm B
direct liver surgery
No interventions assigned to this group
Interventions
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Trans arterial chemoembolization with Irinotecan Drug-eluting Beads
preoperative chemoembolization with Irinotecan Drug-eluting Beads
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Locations
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Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PIDUC
Identifier Type: -
Identifier Source: org_study_id
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