- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00730860
Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation (RFA) Associated With Postoperative TACE
March 27, 2017 updated by: feng xiaobin, Southwest Hospital, China
Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation Associated With Postoperative Transhepatic Arterial Chemoembolization--a Prospective Randomized Clinical Trial
A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by RFA associated with postoperative TACE.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Feng Xiaobin, M.D
- Phone Number: +86-23-68765297
- Email: fengxiaobin200708@yahoo.com.cn
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400038
- Recruiting
- Institute of hepatobiliary surgery
-
Contact:
- Ma Kuansheng, Ph.D
- Phone Number: 86-23-68765297
- Email: xiaobinf@medmail.com.cn
-
Principal Investigator:
- Feng Xiaobin, M.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RFA+TACE
treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization
|
treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization
Other Names:
|
Active Comparator: RFA only
treatment of hepatocellular carcinoma by radiofrequency ablation only
|
treatment of hepatocellular carcinoma by radiofrequency ablation only
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
disease free survival
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2009
Primary Completion (Anticipated)
January 30, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
August 6, 2008
First Submitted That Met QC Criteria
August 6, 2008
First Posted (Estimate)
August 8, 2008
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SWHB002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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