Raltitrexed based Transcatheter Arterial Chemoembolization (TACE) forUnresectable Hepatocellular Carcinoma: A Single-center Randomized ControlledStudy

Background: We aimed to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE), a combination of raltitrexed, oxaliplatin, and epirubicin, for unresectable hepatocellular carcinoma (HCC). Methods: We enrolled 163 patients in this single-center, randomized, controlled trial comparing TACE with epirubicin and oxaliplatin (control group; 83 patients) to TACE with raltitrexed, epirubicin, and oxaliplatin (raltitrexed group; 80 patients).The primary endpoint was overall survival(OS);secondary endpoints included progression-free survival(PFS),tumor response and adverse events. Results: The median progression-free survival (mPFS) and overall survival (mOS) were similar (mPFS: 4.3 vs. 4.6 months, P = 0.201; mOS: 9.6 vs. 9.8 months, P = 0.698, respectively). The disease control rates for the control and raltitrexed groups were 57.8% and 63.8%, respectively, and did not reach statistical significance (P = 0.439). Adverse events were also similar in both the groups (P u003e 0.05). Conclusion: Although the study did not meet its primary endpoint, the treatment induced a high response rate and promising PFS and OS rates in patients, suggests that the use of raltitrexed as an alternative for TACE may confer some benefit to patients with unresectable HCC.