Status:
UNKNOWN
Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis
Lead Sponsor:
Fudan University
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04912258
Start Date
August 1 2021
End Date
June 1 2023
Last Update
June 3 2021
Active Locations (1)
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1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032