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

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Irinotecan

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