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

Primary Purpose

Cancer of Liver

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radiofrequency ablation associated with TACE
radiofrequency ablation only
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Liver focused on measuring radiofrequency ablation, Cancer of Liver, postoperative, transhepatic arterial chemoembolization, prospective

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute of hepatobiliary surgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RFA+TACE

RFA only

Arm Description

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

treatment of hepatocellular carcinoma by radiofrequency ablation only

Outcomes

Primary Outcome Measures

disease free survival

Secondary Outcome Measures

overall survival

Full Information

First Posted
August 6, 2008
Last Updated
March 27, 2017
Sponsor
Southwest Hospital, China
Collaborators
Agency for Science, Technology and Research
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1. Study Identification

Unique Protocol Identification Number
NCT00730860
Brief Title
Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation (RFA) Associated With Postoperative TACE
Official Title
Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation Associated With Postoperative Transhepatic Arterial Chemoembolization--a Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (Actual)
Primary Completion Date
January 30, 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
Collaborators
Agency for Science, Technology and Research

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Liver
Keywords
radiofrequency ablation, Cancer of Liver, postoperative, transhepatic arterial chemoembolization, prospective

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RFA+TACE
Arm Type
Experimental
Arm Description
treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization
Arm Title
RFA only
Arm Type
Active Comparator
Arm Description
treatment of hepatocellular carcinoma by radiofrequency ablation only
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation associated with TACE
Other Intervention Name(s)
Group A
Intervention Description
treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation only
Other Intervention Name(s)
Group B
Intervention Description
treatment of hepatocellular carcinoma by radiofrequency ablation only
Primary Outcome Measure Information:
Title
disease free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Xiaobin, M.D
Phone
+86-23-68765297
Email
fengxiaobin200708@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ma Kuansheng, Ph.D
Organizational Affiliation
Institute of hepatobiliary surgery,Southwest Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Institute of hepatobiliary surgery
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Kuansheng, Ph.D
Phone
86-23-68765297
Email
xiaobinf@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Feng Xiaobin, M.D

12. IPD Sharing Statement

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

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