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

NCT ID: NCT00730860

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2018-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cancer of Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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RFA+TACE

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

Group Type EXPERIMENTAL

radiofrequency ablation associated with TACE

Intervention Type PROCEDURE

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

RFA only

treatment of hepatocellular carcinoma by radiofrequency ablation only

Group Type ACTIVE_COMPARATOR

radiofrequency ablation only

Intervention Type PROCEDURE

treatment of hepatocellular carcinoma by radiofrequency ablation only

Interventions

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radiofrequency ablation associated with TACE

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

Intervention Type PROCEDURE

radiofrequency ablation only

treatment of hepatocellular carcinoma by radiofrequency ablation only

Intervention Type PROCEDURE

Other Intervention Names

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Group A Group B

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Science, Technology and Research

OTHER

Sponsor Role collaborator

Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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feng xiaobin

Dr Xiaobin Feng

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ma Kuansheng, Ph.D

Role: STUDY_DIRECTOR

Institute of hepatobiliary surgery,Southwest Hospital

Locations

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Institute of hepatobiliary surgery

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Feng Xiaobin, M.D

Role: CONTACT

+86-23-68765297

Facility Contacts

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Ma Kuansheng, Ph.D

Role: primary

86-23-68765297

Other Identifiers

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SWHB002

Identifier Type: -

Identifier Source: org_study_id

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