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

June 2, 2021 updated by: Fudan University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months
from liver surgery to liver relapse
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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