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Liver Diseases

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Epirubicin

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Idarubicin

Ethiodized Oil

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10mg idarubicin is dissolved in 5ml water for injection, and 5\~20ml lipiodol is used to prepare lipiodol emulsion.

50mg epirubicin is dissolved in 5ml 5% glucose solution, and 5\~20ml lipiodol is used to prepare lipiodol emulsion.

After an interventional treatment, CT and/or MRI, tumor-related markers, liver and kidney function and blood routine examinations will be reviewed every 4-6 weeks, based on the patient's response to the last treatment, changes in liver function and physical fitness, and CT And (or) dynamic enhanced MRI scan to evaluate the survival of liver tumors and determine the next TACE treatment. At least 2 cycles are applied and no more than 4 cycles are applied.

Idarubicin Hydrochloride for Injection

guoliang shao

In this study, patients with hepatocellular carcinoma were used as the research object to explore the effectiveness and safety of idarubicin hepatic artery perfusion combined with lipiodol embolization, and to preliminarily explore the possibility of idarubicin in the treatment of hepatocellular carcinoma. Provide evidence-based medicine for the discovery of better TACE combined chemotherapy regimens for the treatment of hepatocellular carcinoma.

China is a country with a high incidence of liver cancer, the annual incidence of nearly 50% of the world. At present, transcatheter Arterial chemoembolization (TACE) has become one of the main treatment methods for primary liver cancer and liver metastasis, and has been recognized as the first choice for inoperable primary liver cancer. In addition, it has also been applied in the treatment of resectable liver cancer, liver cancer with tumor embolus and liver metastasis, which is safe and reliable.

Idarubicin is a DNA topoisomerase II inhibitor that promotes DNA strand breakage, trapping cells in the G2 phase of the cell cycle, DNA cleavage, and cell apoptosis. At the same time, it can be inserted between the DNA base pairs and create freedom. Preclinical studies have shown that Idarubicin has superior 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 Idarubicin TACE, and have obtained positive results.

This study aims to evaluate the safety and effectiveness of idarubicin lipiodol emulsion hepatic artery chemoembolization in the treatment of hepatocellular carcinoma, in order to provide evidence-based medical evidence for the discovery of a better TACE treatment regimen for advanced hepatocellular carcinoma.

Idarubicin vs. Epirubicin TACE in the Treatment of Hepatocellular Carcinoma

A Randomized Controlled, Multi-center Clinical Study of Anbijian (Idarubicin Hydrochloride for Injection) vs. Epirubicin Lipiodol Emulsion Transhepatic Arterial Chemoembolization in the Treatment of Hepatocellular Carcinoma

The number of cases that achieved complete remission (CR) or partial remission (PR) accounted for the percentage of patients with evaluable efficacy.

The number of complete remission (CR), partial remission (PR) and stable disease (SD) cases accounted for the percentage of patients with evaluable efficacy.

After a period of follow-up, the proportion of patients who are still alive. Observation in this study 1-year survival rate and 2-year survival rate

Time from start of TACE treatment to disease progression

Time from the start of TACE treatment to death from any cause

Zhejiang Cancer Hospital

The initial dose of idarubicin is 10 mg and the maximum tolerated dose is 20 mg. Idarubicin is first dissolved in water for injection to make a solvent of 2mg/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.

Gao-Jun Teng, MD

Hai-Dong Zhu, MD

The purpose of this real-world study is to evaluate the safety and efficacy of lipiodol-TACE with idarubicin for hepatocellular carcinoma.

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. At the same time, it can be inserted between the DNA base pairs and produce free radicals, thus breaking the DNA double helix structure and inhibiting the extension, replication and transcription of DNA strands. Preclinical studies have shown that idarubicin has higher antitumor activity than epirubicin, especially against SUN-449 human hepatoma cells. In recent years, domestic and foreign scholars have conducted a series of explorations in the treatment of hepatocellular carcinoma with lipiodol-idarubicin emulsion, and have obtained positive results. This proepective， multicenter real-worldstudy aims to evaluate the efficacy and safety of lipiodol-TACE with idarubicin in Chinese HCC patients.

Lipiodol-TACE With Idarubicin for Hepatocellular Carcinoma

Transarterial Chemoembolization With Lipiodol-Idarubicin Emulsion in the Treatment of Hepatocellular Carcinoma: a Prospective, Multicenter, Real-world Study

The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) \[mRECIST\].

The DCR is defined as the percentage of participants who have the overall response of CR, PR, or stable disease (SD) \[mRECIST\].

The TTP is defined as the time from the initiation TACE to tumor progression \[mRECIST\].

The OS is defined as the time from the initiation TACE to death from any cause.

The proportion of patients who are still alive during the follw-up period.

Incidence and severity of adverse events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Idarubicin vs. Epirubicin TACE in the Treatment of Hepatocellular Carcinoma	NCT05053386	Hepatocellular ...	Idarubicin Hydr... Epirubicin	18 Years - 80 Years	Zhejiang Cancer Hospital
Lipiodol-TACE With Idarubicin for Hepatocellular Carcinoma	NCT05280444	Hepatocellular ...	Idarubicin Hydr...	18 Years - 75 Years	Zhongda Hospital
Idarubicin vs. Epirubicin TACE in the Treatment of Hepatocellular Carcinoma	NCT05053386	Hepatocellular ...	Idarubicin Hydr... Epirubicin	18 Years - 80 Years	Zhejiang Cancer Hospital
Lipiodol-TACE With Idarubicin for Hepatocellular Carcinoma	NCT05280444	Hepatocellular ...	Idarubicin Hydr...	18 Years - 75 Years	Zhongda Hospital

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