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Trial Title:
Lipiodol-TACE With Idarubicin Based On a Specific Emulsion Ratio for Hepatocellular Carcinoma
NCT ID:
NCT05631613
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular Carcinoma
Transarterial chemoembolization
Idarubicin
Lipiodol emulsion
prospective study
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
cTACE(conventional transarterial chemoembolization)
Description:
transarterial chemoembolization with lipiodol-idarubicin emulsion
Arm group label:
Nonionic Contrast Agent -Idarubicin -Lipiodol
Arm group label:
Water for Injection -Idarubicin -Lipiodol
Summary:
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.
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.
Criteria for eligibility:
Study pop:
patients treated by lipiodol TACE with idarubicin for HCC
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongda Hospital, Southeast University
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Recruiting
Start date:
December 28, 2022
Completion date:
April 30, 2023
Lead sponsor:
Agency:
Zhongda Hospital
Agency class:
Other
Source:
Zhongda Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05631613
