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

Southeast University

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: cTACE(conventional transarterial chemoembolization)

Study type: Observational

Funder types: Other

Identifiers

NCT05631613

Idarubicin-cTACE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Water for Injection -Idarubicin -Lipiodol

Description:

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.

Treatment:

Procedure: cTACE(conventional transarterial chemoembolization)

Nonionic Contrast Agent -Idarubicin -Lipiodol

Description:

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.

Treatment:

Procedure: cTACE(conventional transarterial chemoembolization)