Treatment of hepatcellular carcinoma with neoplastic thrombosis of the main portal vein using sorafenib and percutaneous radiofrequency ablation comparing to Sorafenib alone

INTERVENTION: Participants are randomly allocated to one of two groups: 1. RFA (radiofrequency ablation) of MPVTT (main portal vein tumor thrombus) and HCC (hepatocellular carcinoma) nodules plus sorafenib (combination group) 2. Sorafenib alone (sorafenib alone group) Allocation was carried out prospectively with the use of a coded list compiled from a random number generator; the code was fully blinded to the field staff and trial participants were blinded to the code. The sample size was calculated considering 44% 3‐year survival rate in the control group (Sorafenib alone) and assuming that the experimental group (RFA‐MPVTT plus Sorafenib) woud obtain more than a 20% increase in survival. An alpha error of 0.05 and a study power of about 80% (beta=0.20) were considered. The number of patients per arm was calculated to be more than 37 patients per arm. RFA (percutaneous radiofrequency ablation) of MPVTT (main portal vein tumor thrombus) was performed under unconscious sedation by the same physician (A.G.) with more than 30 years' experience in interventional US and all percutaneous procedures were performed within 7 days of diagnosis. RFA of portal vein tumor thrombus (PVTT) was performed as reported elsewhere. Briefly, RFA of MPVTT was performed under US guidance using a perfused electrode‐needle, (caliber 15 G, exposed tip 1.5‐2.0 cm, according to the thrombus width) connected to an RF generator at a power of 80‐100 Watt for 5‐8 minutes: when the portal trunk appeared completely hyperechoic, the RFA application was considered sufficient and the electrode needle was withdrawn with the RF generator still on, so as to avoid seeding. RFA of the portal thrombus was carried out firstly on the thrombus in the portal vein, taking care to avoid hepatic artery and common bile duct, and then on the hepatocellular carcinoma (HCC) intrahepatic nodule/s. The number of sessions for ablation of both HCC nodules and MPVTT was scheduled as follows: one session in case of HCC nodules CONDITION: Hepatocellular carcinoma in cirrhosis ; Cancer ; Hepatocellular carcinoma PRIMARY OUTCOME: The survival rate, expressed in months, after 12, 24 and 36 months from treatment. INCLUSION CRITERIA: 1. Child‐Pugh A 5‐6 liver cirrhosis 2. A single HCC nodule < 6.5 cm in diameter and concomitant main portal vein tumor thrombus (MPVTT) 3. Maximum 3 HCC nodules with the largest one no more than 5 cm with MPVTT