Neoplasms

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Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Chlorotrianisene

Idarubicin

Ethiodized Oil

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.

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.

transarterial chemoembolization with lipiodol-idarubicin emulsion

cTACE(conventional transarterial chemoembolization)

Hai-Dong Zhu, MD

Hui-Yan Dong, MD(studying)

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.

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.

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

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

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

Observe and assess the separation of emulsion（when it occures, record the percentage of aqueous phase, the persisting emulsion and the oily phase）

Observe the tube-adhesion of emulsion.The subjective perception of injection is evaluated by questionnaire.

Assessed by two or more senior radiologists according to Subjective Relative Evaluation of Images.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Lipiodol-TACE With Idarubicin Based On a Specific Emulsion Ratio for Hepatocellular Carcinoma	NCT05631613	Hepatocellular ...	cTACE(conventio...	18 Years - 80 Years	Zhongda Hospital
Lipiodol-TACE With Idarubicin Based On a Specific Emulsion Ratio for Hepatocellular Carcinoma	NCT05631613	Hepatocellular ...	cTACE(conventio...	18 Years - 80 Years	Zhongda Hospital

Spots Global Cancer Trial Database for ctace(conventional transarterial chemoembolization)