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

Phase 3

• Conditions: Colorectal Cancer; Liver Metastases
• Interventions: Drug: Trans arterial chemoembolization with Irinotecan Drug-eluting Beads

• Registration Number: NCT04912258
• Lead Sponsor: Fudan University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Last Update Submitted: 2021-06-02
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03
• Study Start: 2021-08-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Trans arterial chemoembolization with Irinotecan Drug-eluting Beads	DEB-TACE before liver surgery

Primary Outcome Measures

Name	Time	Method
liver relapse-free survival	6 months	from liver surgery to liver relapse

Secondary Outcome Measures

Name	Time	Method
response rate	2 months
relapse-free survival	6 months
overall survival	12 months

Trial Locations

Locations (1)

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China