Objective: To study the clinical safety and effect on local recurrence in unresectable small hepatocellular carcinoma treated by radiofrequency ablation (RFA) with and without chemotherapy through a prospective randomized trial.
Methods: Thirty-eight unresectable small hepatocellular carcinoma patients with diameter </= 3 cm were selected, of which 27 patients have been followed up for 1 year. Through a prospective randomized trial, 12 patients were in the RFA group and 15 patients in the RFA combined with systemic chemotherapy group. RFA was given image-guided. The regimen of systemic chemotherapy: EADM 50 mg on day 1, 3; CDDP 40 mg on day 1, 3 and FUDR 500 mg on day 1, 2, 3. After RFA treatment, liver function, WBC count and complications were observed on day 1, 4, 7; CT scan was performed in 1, 6, 12 months. The safety and local recurrence were analyzed.
Results: There was no local recurrence of the tumor in the two groups 1 month after RFA treatment. The 6- and 12-month local recurrence rates were significantly lower in the combined group than that in RFA group alone (P < 0.01). There were no severe complications in the two groups, and nor was there any significant difference in liver function and WBC count.
Conclusion: RFA combined with systemic chemotherapy is safe, and it can reduce the local recurrence of unresectable small hepatocellular carcinoma </= 3 cm in diameter.