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

Sponsor

Southwest Hospital, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT00730860

Collaborator

Agency for Science, Technology and Research (Other)

140

Enrollment

Location

Arms

102

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer of Liver	Procedure: radiofrequency ablation associated with TACE Procedure: radiofrequency ablation only	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation Associated With Postoperative Transhepatic Arterial Chemoembolization--a Prospective Randomized Clinical Trial

Actual Study Start Date :

Dec 1, 2009

Anticipated Primary Completion Date :

Jan 30, 2018

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RFA+TACE treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization	Procedure: radiofrequency ablation associated with TACE treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization Other Names: Group A
Active Comparator: RFA only treatment of hepatocellular carcinoma by radiofrequency ablation only	Procedure: radiofrequency ablation only treatment of hepatocellular carcinoma by radiofrequency ablation only Other Names: Group B

Arm

Intervention/Treatment

Experimental: RFA+TACE

treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization

Procedure: radiofrequency ablation associated with TACE

treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization

Other Names:

Group A

Active Comparator: RFA only

treatment of hepatocellular carcinoma by radiofrequency ablation only

Procedure: radiofrequency ablation only

treatment of hepatocellular carcinoma by radiofrequency ablation only

Other Names:

Group B

Outcome Measures

Primary Outcome Measures

disease free survival [3 years]

Secondary Outcome Measures

overall survival [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.