Colorectal Cancer, Liver Metastases
Conditions
Brief summary
Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis
Interventions
DRUGTrans arterial chemoembolization with Irinotecan Drug-eluting Beads
preoperative chemoembolization with Irinotecan Drug-eluting Beads
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| liver relapse-free survival | 6 months | from liver surgery to liver relapse |
Secondary
| Measure | Time frame |
|---|---|
| relapse-free survival | 6 months |
| overall survival | 12 months |
| response rate | 2 months |
Countries
China
Contacts
Primary ContactJianmin Xu
Outcome results
None listed