Objective: To evaluate the safety and efficacy of combined transarterial chemoembolization (TACE) and Apatinib Mesylate Tablets in patients with advanced hepatocellular carcinoma (HCC). Methods: A prospective single-center phase Ⅱ study was undertaken involving patients with unresectable HCC. The protocol involved Apatinib 500 mg once per day combined with TACE. The safety and efficacy were assessed. Results: Apatinib in combination with TACE was successfully administered in 30 patients with averaged age of 66 years, 80.6% rated in Child-Pugh A, 51.6% and 48.4% respectively in Eastern Cooperative Oncology Group performance status of 0 and averaged tumor size of 6.5 cm. Patients underwent 60 cycles of therapy. Median number of cycles per patients was two (range, one to five cycles). The most common toxicities during the first cycle were fatigue (97.5%), hypertension (75.2%), elevated total bilirubin (65.3%), and dermatologic adverse effects (39.6%). Although the patients experienced at least one grade 3 or 4 toxicity, the most toxicities were minor ones (grade 1 to 2, 85%; grade 3 to 4, 15%). Toxicity during the second cycle was decreased. Over the course of the study, there were 21 Apatinib dose interruptions and 18 Apatinib dose reductions. Apatinib plus TACE was associated with a disease control rate of 87.5% (Response Evaluation Criteria in Solid Tumors Group, RECIST criterion), with an objective response of 10%. Conclusions: The combination of Apatinib and TACE in patients with unresectable HCC is well tolerated and safe, with most of the toxicities related to Apatinib. Toxicity is manageable with dose adjustment of Apatinib. Preliminary efficacy data are promising. |