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NCT00730860 Clinical Trial

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

Cancer of Liver Clinical Trial

Official title:
Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation Associated With Postoperative Transhepatic Arterial Chemoembolization——a Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00730860
Other study ID # SWHB002
Secondary ID
Status Recruiting
Phase N/A
First received August 6, 2008
Last updated March 27, 2017
Start date December 2009
Est. completion date June 2018

Study information
Verified date March 2017
Source Southwest Hospital, China
Contact Feng Xiaobin, M.D
Phone +86-23-68765297
Email fengxiaobin200708@yahoo.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date June 2018
Est. primary completion date January 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• radiofrequency ablation associated with TACE
treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization
• radiofrequency ablation only
treatment of hepatocellular carcinoma by radiofrequency ablation only

Locations
Country Name City State
China Institute of hepatobiliary surgery Chongqing Chongqing

Sponsors (2)
Lead Sponsor Collaborator
Southwest Hospital, China Agency for Science, Technology and Research

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary disease free survival 3 years
Secondary overall survival 3 years
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