Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis

Fudan University

Status and phase

Unknown

Phase 3

Conditions

Liver Metastases

Colorectal Cancer

Treatments

Drug: Trans arterial chemoembolization with Irinotecan Drug-eluting Beads

Study type

Interventional

Funder types

Other

Identifiers

NCT04912258

PIDUC

Details and patient eligibility

About

Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis

Enrollment

80 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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