The Efficacy and Safety of Adjuvant TACE in Radical Surgery for Hepatocellular Carcinoma With High-risk Recurrence Factors: A Phase III Randomized Controlled Clinical Study

What this Trial Is About

Researchers are evaluating the impact of adjuvant transarterial chemoembolization (TACE) on recurrence-free survival in patients with hepatocellular carcinoma (HCC) who have high-risk factors for recurrence after curative hepatectomy. This Phase III randomized controlled trial addresses the controversy over adjuvant TACE's effectiveness, comparing it to intensive follow-up alone. The trial aims to clarify if TACE reduces postoperative recurrence and improves overall survival, with safety and adverse events also monitored. Participants will be randomly assigned to one of two groups. The adjuvant TACE group will receive a single treatment involving embolization with lobaplatin and ethiodized poppyseed oil near the hepatic resection margin after surgery. The intensive follow-up group will undergo hepatic arteriography without embolization or chemotherapy. Both groups will have post-procedure care including catheter removal and hemostasis. During the study, participants will be closely monitored for recurrence through follow-up assessments. Researchers will measure recurrence-free survival over two years, overall survival, treatment-related adverse events, and the time to recurrence. The study includes careful evaluation of safety and treatment discontinuation rates, with the total participation spanning a period sufficient to capture these outcomes.

Adjuvant TACE in HCC With High-risk Recurrence Factors