A new thermosensitive embolic agent used for arterial embolization of primary hepatocellular carcinoma:preliminary clinical trial / 介入放射学杂志

ABSTRACT

Objective To investigate the clinical application of a new thermosensitive embolic agent in interventional arterial embolization treatment, and to evaluate its effectiveness and safety in treating inoperable advanced hepatocellular carcinoma (HCC). Methods Prospective, open and single center clinical study of a new thermosensitive embolic agent was conducted. A total of 10 patients with clinically confirmed inoperable advanced HCC were treated with percutaneous arterial embolization using thermosensitive embolic agent; a maximum of 4 therapeutic cycles were performed until the disease progressed. Objective effect was evaluated at (30 ±7) days after the treatment according to mRECIST standard; the progression free survival (PFS) time and the survival period (OS) were recorded. The adverse reactions and adverse events were determined by NCI-CTC 3.0 version standard. Results Ten patients (23 target lesions in total) were enrolled in this study. After the treatment, complete remission (CR) was obtained in one patient, partial remission (PR) in 3 patients, stable disease (SD) in 5 patients, and progress disease (PD) in one patient. The objective response rate (CR+PR) was 40%, and the disease control rate (CR+PR+SD) was 90%. The PFS of hepatic lesions was 18.4 weeks (95%CI14.15-22.65), the cumulated median survival period was 46.2 weeks (95%CI38.18-54.22). The most common adverse reactions included pain, fever, hepatic function damage, small amount of ascites, diarrhea, etc. Conclusion The new thermosensitive embolic agent is not sticky to vessel and is visible under X-ray; it has reliable embolization effect, and the therapeutic results can be easily evaluated. This embolic agent is not perfect, and it has some limitations in clinical use. The adverse reactions are mild, which can be easily tolerated by the patients. It is worth trying to carry out large sample and randomized controlled studies in order to open up more areas for arterial chemoembolization therapy of tumors.