Lipiodol-TACE With Idarubicin Based On a Specific Emulsion Ratio for Hepatocellular Carcinoma

December 28, 2022 updated by: Gao-jun Teng, Zhongda Hospital

Transarterial Chemoembolization With Lipiodol-Idarubicin Emulsion Based On a Specific Ratio for Hepatocellular Carcinoma:a Prospective, Observational Study

The purpose of this observational study is to evaluate properties of lipiodol-idarubicin emulsion mixed with the best regimen obtained in vitro study, including stability, viscosity，visibility under X-ray and deposition, in order to maximize the efficacy of idarubicin-cTACE for HCC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Idarubicin is a DNA topoisomerase II inhibitor that promotes DNA strand breakage, trapping cells in the G2 phase of the cell cycle and inducing DNA cleavage and cell apoptosis. Preclinical studies have shown that idarubicin has higher antitumor activity than epirubicin, especially against SUN-449 human hepatoma cells.

In recent years, foreign scholars have conducted a series of explorations in the treatment of hepatocellular carcinoma with lipiodol-idarubicin emulsion, and have obtained positive results.

However, in China, idarbicin has just been applied to TACE.Many interventional physicians are accustomed to directly use contrast agents to dissolve anthracyclines in order to improve tracer performance of chemotherapeutic agent-lipiodol emulsion under X-ray and reduce intraoperative reflux and misembolization. Meanwhile, due to the high density of the nonionic contrast media, the lipiodol emulsion can be deposited in the lesion for a long time. The Clinical Practice Guidelines for transcatheter arterial chemoembolization (TACE) Treatment of hepatocellular carcinoma in China (2021 edition) also recommended to prepare the chemotherapeutic drug-lipiodol emulsion according to the standard of " dissolving drug in nonionic contrast agent then mixed with lipiodol to make an emulsion with a ratio of 1:2".

At present, there is a lack of detailed objective data on the complete physical properties of the lipiodol-idarubicin emulsion, and some physicians and centers even make the emulsion based only on their habits and preferences.These all may affect the physical properties of the lipiodol emulsion, including intraoperative stability and viscosity of the emulsion, then eventually affect the operation of surgeon and the release behavior of chemotherapeutic drugs, and ultimately influence the efficacy of TACE.Therefore, the purpose of this prospective, observational study is to evaluate properties of lipiodol-idarubicin emulsion mixed with the best regimen obtained in vitro study, including stability, viscosity，visibility under X-ray and deposition, in order to maximize the efficacy of idarubicin-cTACE for HCC.

Study Type

Observational

Enrollment (Anticipated)

40

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

Study Contact Backup

  • Name: Hui-Yan Dong, MD(studying)
  • Phone Number: +86-02583272121
  • Email: ljxxdhy@126.com

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital, Southeast University

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients treated by lipiodol TACE with idarubicin for HCC

Description

Inclusion Criteria:

  1. Confirmed diagnosis of HCC according to histopathology or CNLC guidelines (2022 Edition);
  2. One of the following cases:

1）CNLC stage IIb-IIIa, part of stage IIIb, and CNLC stage Ib and IIa patient who is unable or unwilling to receive surgical treatment due to other reasons (such as advanced age, severe liver cirrhosis, etc.); 2).Child-Pugh class A or B; 3).ECOG PS of 0 - 2; 4)The main portal vein has not been completely obstructed, with abundant collateral vessels, or restore the blood flow by portal vein stent placement 3.At least one measurable lesion (enable to assess lipiodol deposition); 4.Be willing to participate in this study.

Exclusion Criteria:

  1. Non-HCC patients treated with TACE
  2. Incomplete clinical and imaging data
  3. Poor image quality or other difficulties in assessing intratumoral lipiodol deposition, including:

1) A large amount of lipiodol was deposited around the lesion 2) Diffuse tumor distribution 3) Intratumoral lipiodol deposition from previous TACE 4) Metal artifacts from previous operations

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Water for Injection -Idarubicin -Lipiodol

Idarubicin is first dissolved in water for injection to make a solvent of

1mg/ml, which is then mixed with lipiodol to make an emulsion with a ratio of 1:2. Lipiodol-idarubicin emulsion is slowly injected, followed by embolization with embolic agents.
Procedure: cTACE(conventional transarterial chemoembolization)
transarterial chemoembolization with lipiodol-idarubicin emulsion
Nonionic Contrast Agent -Idarubicin -Lipiodol

Idarubicin is first dissolved in nonionic contrast agent to make a solvent of

1mg/ml, which is then mixed with lipiodol to make an emulsion with a ratio of 1:2. Lipiodol-idarubicin emulsion is slowly injected, followed by embolization with embolic agents.
Procedure: cTACE(conventional transarterial chemoembolization)
transarterial chemoembolization with lipiodol-idarubicin emulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deposition of of lipiodol-idarubicin emulsion
Time Frame: intraoperative and up to 7 days
1. Assessed by two or more senior radiologists as described in previous works: Excellent：>90%；Good：50%-90%；Poor：<50% 2.3D quantitative assessments of intratumoral lipiodol-emusion using the software 3d-slicer： V1=Volume of tumor (cm3) V2=volume of lipiodol deposition (cm3) Degree of iodized oil uptake:Intratumoral lipiodol retention(%)=V1/V2
intraoperative and up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stability of lipiodol-idarubicin emulsion
Time Frame: intraoperative
Observe and assess the separation of emulsion（when it occures, record the percentage of aqueous phase, the persisting emulsion and the oily phase）
intraoperative
Viscosity of lipiodol-idarubicin emulsion
Time Frame: intraoperative
Observe the tube-adhesion of emulsion.The subjective perception of injection is evaluated by questionnaire.
intraoperative
Visibility of lipiodol-idarubicin emulsion under X-ray: image quality
Time Frame: intraoperative and up to 7 days
Assessed by two or more senior radiologists according to Subjective Relative Evaluation of Images.
intraoperative and up to 7 days

Collaborators and Investigators

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

Sponsor

Zhongda Hospital

Investigators

  • Principal Investigator: Hai-Dong Zhu, MD, Zhongda hospital, Southeast university, Nanjing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 28, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

November 19, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Idarubicin-cTACE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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