论文部分内容阅读
Objective:New systemic therapies are needed to improve the prognosis of patients with advanced-stage hepatocellular carcinoma.The study was conducted to determine the efficacy and safety of viscum fraxini-2 in advanced Hepatocellular carcinoma.Methods:A phase Ⅱ study with a two-stage design that enrolled a total of 120 patients with chemotherapy na(i)ve advanced hepatocellular carcinoma.The mistletoe preparation for the study is an aqueous injectable solution that contains one milliliter of viscum fraxini.Two ampoules of viscum fraxini were administered subcutaneously once weekly.Results:Chronic hepatitis C virus infection was the predominant cause of liver disease (60%) in studied cases.According to the response evaluation criteda in solid tumors 24 patients (20%) achieved objective response (including 2 complete responses) and 40 patients (33.3%) achieved stable disease.The median progression free survival for all patients was 4 months (range 1-28 months;95% CI 3.3:4.7 months).The median overall survival for all patients was 8 months (range 1-28 months;95% CI 6.3:9.7 months).The median survival for patients who achieved responsive or stable disease was 16 months.The toxicity was generally mild and well tolerated,mainly in the form of local reaction and fever.There were no drug related discontinuation or toxic deaths.Conclusion:Viscum fraxini-2 is an effective,safe treatment for patients with advanced hepatoceilular carcinoma.Further randomized controlled trials are recommended.