Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation (RFA) Associated With Postoperative TACE
1 other identifier
interventional
140
1 country
1
Brief Summary
A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by RFA associated with postoperative TACE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMarch 28, 2017
March 1, 2017
8.2 years
August 6, 2008
March 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease free survival
3 years
Secondary Outcomes (1)
overall survival
3 years
Study Arms (2)
RFA+TACE
EXPERIMENTALtreatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization
RFA only
ACTIVE COMPARATORtreatment of hepatocellular carcinoma by radiofrequency ablation only
Interventions
treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization
treatment of hepatocellular carcinoma by radiofrequency ablation only
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of hepatobiliary surgery
Chongqing, Chongqing Municipality, 400038, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ma Kuansheng, Ph.D
Institute of hepatobiliary surgery,Southwest Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Xiaobin Feng
Study Record Dates
First Submitted
August 6, 2008
First Posted
August 8, 2008
Study Start
December 1, 2009
Primary Completion
January 30, 2018
Study Completion
June 1, 2018
Last Updated
March 28, 2017
Record last verified: 2017-03