Combined Treatment of RFA and Sorafenib on Recurrent HCC

Not Applicable

• Conditions: Sorafenib; HCC; Radiofrequency Ablation
• Interventions: Other: RFA; Other: RFA + Sorafenib

• Registration Number: NCT01470495
• Lead Sponsor: Southwest Hospital, China

Brief Summary

RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a promising drug to treat late stage HCC. But few studies were related with its effectiveness on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might reduce the frequency of recurrence and improve the overall survival and disease free survial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Study Start: 2015-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

• recurrent HCC after curative resection
• without gender restriction
• age between 18 to 75 years
• The liver function showed no worse than Child-Pugh B
• tumor nodes were less than 5cm and no more than 3 nodules

Exclusion Criteria

• Pregnancy patients
• With extrahepatic tumor or lymphnode metastasis
• Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA group	RFA	To treat recurrent HCC with RFA
RFA+Sorafenib	RFA + Sorafenib	to treat recurrent HCC both with RFA and Sorafenib

Primary Outcome Measures

Name	Time	Method
time interval between new lessions emerging after the first HCC recurrence	3 year

Secondary Outcome Measures

Name	Time	Method
3-year overrall survival	3 year

Trial Locations

Locations (1)

Institute of hepatobiliary surgery,southwest hospital; 🇨🇳 Chongqing, Chongqing, China