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

Sorafenib combined with percutaneous radio-frequency ablation of both hepatocellular carcinoma nodule and portal vein tumor thrombus compared with sorafenib alone: a western randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95691970

Enrollment

100

Registered

2016-07-26

Start date

2011-06-07

Completion date

Unknown

Last updated

2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma in cirrhosis Cancer Hepatocellular carcinoma

Interventions

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 s

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Patients with ascites 2. Patients with bilirubin >2 mg/dl 3. Patients and with extrahepatic spread of disease

Design outcomes

Primary

Measure	Time frame
The survival rate, expressed in months, after 12, 24 and 36 months from treatment.	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026