Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation (RFA) Associated With Postoperative TACE

Not Applicable

• Conditions: Cancer of Liver
• Interventions: Procedure: radiofrequency ablation associated with TACE; Procedure: radiofrequency ablation only

• Registration Number: NCT00730860
• Lead Sponsor: Southwest Hospital, China

Brief Summary

A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by RFA associated with postoperative TACE.

Detailed Description

A randomized study was conducted to elucidate whether the outcome of hepatocellular carcinoma could be improved by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization.

Study Timeline

• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-08
• Study Start: 2009-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28
• Primary Completion: 2018-01-30
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• patients with hepatocellular,confirmed by pathological examination
• patients with a live function test showed Child A or B
• Indocyanine green test showed less than 30％ after 15min,and the patients showed a tolerance of RFA and TACE
• Tumor stage is early period(according to Milan Standard),that is,the diameter of single node should be less than 5cm；the node of tumor should be less than 3 and the diameter less than 3cm.
• without metastasis in lymphnode or other organs
• written consent inform assigned

Exclusion Criteria

• preoperative examination showed malignant thrombosis in the first class branch of portal vein or hepatic vein or vena cava
• metastatic cancer of liver
• patients with a poor tolerance of RFA and TACE
• patients received other therapies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA+TACE	radiofrequency ablation associated with TACE	treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization
RFA only	radiofrequency ablation only	treatment of hepatocellular carcinoma by radiofrequency ablation only

Primary Outcome Measures

Name	Time	Method
disease free survival	3 years

Secondary Outcome Measures

Name	Time	Method
overall survival	3 years

Trial Locations

Locations (1)

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