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

Trans-arterial Chemoembolization With Irinotecan Drug-eluting Beads Before Liver Surgery for Patients With Primary Unresectable Colorectal Liver Metastasis: A Randomized Control Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Liver Metastases
• Intervention / Treatment: Drug: Trans arterial chemoembolization with Irinotecan Drug-eluting Beads

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jianmin Xu; Phone Number: +8613501984869 +8613501984869; Email: xujmin@aiiyun.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Fudan University
      • Contact: Jianmin Xu; Phone Number: 18834823867 18834823867; Email: 13301050195@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; DEB-TACE before liver surgery	Drug: Trans arterial chemoembolization with Irinotecan Drug-eluting Beads; preoperative chemoembolization with Irinotecan Drug-eluting Beads; Other Names: Irinotecan Drug-eluting Beads
No Intervention: Arm B; direct liver surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
liver relapse-free survival	from liver surgery to liver relapse	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
response rate	2 months
overall survival	12 months
relapse-free survival	6 months

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan
• Other Study ID Numbers: PIDUC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No