TACE+RFA Versus TACE Alone for Intermediate-stage Hepatocellular Carcinoma

October 12, 2016 updated by: Ming Zhao

Transarterial Chemoembolization Plus Radiofrequency Ablation Versus Transarterial Chemoembolization Alone for Intermediate-stage Hepatocellular Carcinoma

The current standard treatment for intermediate-stage HCC (BCLC stage B) is transcatheter arterial chemoembolization (TACE) alone.The combination of TACE with RFA has also reported to be an effective treatment for HCC. Some prospective studies have shown TACE combined RFA to have better efficacy than any of them alone for early stage HCC (single tuomor ≤5 cm). However, to the investigators' knowledge, there have not been any prospective studies to assess whether TACE combined sequentially with RFA is more effective than TACE alone for the treatment of intermediate-stage HCC. The investigators hypothesized that the combination of TACE and RFA might result in better patient survival than TACE alone. Thus, the purpose of this study was to prospectively compare the effects of sequential TACE-RFA with TACE alone for the treatment of intermediate-stage HCC. Intermediate-stage HCC in this study was defined as 2-3 intrahepatic lessions, largest tumor size 3-7 cm or 4-10 intrahepatic lessions, largest tumor size ≤7 cm; ECOG-PS 0;Child-pugh A or B;no tumor thrombus or extrahepatic metastases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1

Phase

  • Phase 4

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

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 500060
        • Recruiting
        • Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,
        • Contact:
        • Contact:

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:

  • Multiple HCC (2-3 lesions), largest lesion 3-7 cm in diameter, or multiple HCC (4-10 lesions), each ≤ 7 cm in diameter
  • No vascular invasion or etrahepatic metastases
  • Eastern Cooperative Oncology Group Performance Status 0-1
  • Child-Pugh Stage A or B
  • Treatment naive

Exclusion Criteria:

  • A platelet counts of <40×109/L，prothrombin time activity <40%;
  • Albumin >2.8 g/dL, total bilirubin <51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）<5 times of upper limit
  • No evaluale target lesions
  • Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy
  • Severe heart, brain or kidney diseases
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC
  • Pregnant women or lactating women
  • Be allergic to adriamycin, lobaplatin, mitomycin and iodized oil

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: TACE-RFA
1-2 times of TACE treatment, then followed by RFA treatment.
Procedure: TACE
TACE will be done according to the current method in our center. We use intra-injection of lipiodol mixed with pirarubicin,mitomycin and lobaplatin when the catheter was placed in the superselective location very close to the tumor. Gelfoam sponge was then injected to temporarily occlude the arterial blood flow.
Procedure: RFA
For RFA, we used two commercially available system (Cool-Tip, Valleylab，USA) and (Octopus RF Systema，Starmed,Korea）with needle electrode with a 17-gauge internally cooled electrode.
Active Comparator: TACE alone
TACE treatment several times till tumor progress to advance stage
Procedure: TACE
TACE will be done according to the current method in our center. We use intra-injection of lipiodol mixed with pirarubicin,mitomycin and lobaplatin when the catheter was placed in the superselective location very close to the tumor. Gelfoam sponge was then injected to temporarily occlude the arterial blood flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival rate
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor progression rate
Time Frame: 2 years
2 years
Tumor progress to advanced-stage rate
Time Frame: 2 years
2 years
Hepatic dysfunction rate
Time Frame: 2 years
2 years
Adverse event rate
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ming Zhao

Investigators

  • Principal Investigator: Ming Zhao, doctor, Principal Investigator, Clinical Professor

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

April 1, 2015

Primary Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

May 3, 2015

First Submitted That Met QC Criteria

May 3, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-FXY-086

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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