Phase I Study of Sorafenib in Combination with Intermittent Hepatic Arterial Infusion Chemotherapy for Unresectable Hepatocellular Carcinoma

ABSTRACT

Objectives: We conducted a phase I study of sorafenib and intermittent hepatic arterial infusion chemotherapy using cisplatin for unresectable hepatocellular carcinoma. Methods: Sorafenib was administered continuously, whereas cisplatin was administered once every 3 weeks. We estimated the safety and efficacy. Results: Fifteen patients were enrolled into this study. The dose-limiting toxicities occurred at sorafenib 800 mg and cisplatin 20 mg/m². The recommended dose was at sorafenib 400 mg and cisplatin 30 mg/m². The disease control rate was 73.3%. Conclusions: This treatment is feasible for unresectable hepatocellular carcinoma. Further evaluation of the regimen in a randomized controlled trial is warranted.

KEYWORDS:

• Chemotherapy
• Clinical trials
• Hepatoma

Declaration of interest

The authors report no declarations of interest. The authors alone are responsible for the content and writing of the article.