The preliminary study of recombinant adenovirus p53 combined with transarterial embolization with particles for advanced hepatocellular carcinoma

Objective: To evaluate the safety and efficacy of transarterial embolization with 350-560 µm Gelatin sponge microspheres (GSMs-TAE) mixed with recombinant adenovirus p53 (rAd-p53, trademarked as Gendicine) in patients with advanced hepatocellular carcinoma (HCC).

Methods: The study was designed as a case-control, single-institution clinical trial. 24 male patients with advanced HCC were included in this study. Tumor response was evaluated by contrast enhanced CT using modified Response Evaluation Criteria in Solid Tumors (mRECIST) after 1-, 6- and 12-month of initial rAd-p53 combined with GSMs -TAE. Adverse events were evaluated by the Common Terminology Criteria for Adverse Effects (CTCAE). Overall survival of all the patients was calculated from the date of initial rAd-p53 combined with GSMs -TAE using the Kaplan-Meier method.

Results: GSMs -TAE was performed 73 times (mean 3.0) in total on 24 patients. All procedures were performed successfully. The mean follow-up period was 14 (range 6-42) months. Complete response (CR) rate after 1-, 6- and 12-month was 25.0%, 33.3% and 37.5% respectively. Objective response (OR) rate was 87.5% , 75.0% and 75.0% after 1-, 6- and 12-month respectively. There were no serious complications such as acute liver failure, liver abscess and pulmonary embolism.

Conclusions: Recombinant adenovirus p53 combined with transarterial embolization with 350-560 µm Gelatin sponge particles for hepatocellular carcinoma is safe and effective.