NCT05280444

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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. 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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Idarubicin Hydrochloride for Injection	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.

Timeline

• Start date: 2022-05-28
• Primary completion: 2023-06-30
• Completion: 2023-07-30
• First posted: 2022-03-15
• Last updated: 2022-12-29

Locations

1 site across 1 country: China