A randomised phase II study of TSU-68 in patients with hepatocellular carcinoma treated by transarterial chemoembolisation

摘要: Abstract Background TSU-68 is an antitumour drug that acts by inhibiting angiogenesis. We evaluated the efficacy and safety of in combination with transarterial chemoembolisation (TACE) patients intermediate-stage hepatocellular carcinoma (HCC). Patients Methods In this multicenter, open-label phase II study, we randomised HCC who had been treated a single session TACE to receive either 200 mg twice daily or no medication. The primary end-point was progression-free survival (PFS). Results A total 103 were enrolled. Median PFS 157.0 days (95% confidence interval [CI], 124.0–230.0 days) group 122.0 days CI, 73.0–170.0 days) control group. hazard ratio 0.699 0.450–1.088). Fatigue, elevated aspartate aminotransferase (AST), alkaline phosphatase, oedema anorexia more frequent than most grade 3/4 adverse events AST elevation (46% 12% controls) alanine (26% 8% controls). Two deaths, 5 hepatic failure melena noted Conclusion This exploratory study shows trend towards prolonged treatment after TACE, but observation not statistically significant. two deaths related treatment. These results suggest further examination design necessary determine whether has any clinical benefits when combined TACE.