TACE+RFA Versus Re-resection for Recurrent Small Hepatocellular Carcinoma (TACE-RFA)

April 12, 2013 updated by: Chen Min-Shan, Sun Yat-sen University

Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Re-resection for Recurrent Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence of HCC after partial hepatectomy is common and was reported to be more than 77% within 5 years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival after initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out only in a small proportion of patients with HCC recurrence (10.4-31%), either because of the poor functional liver reserve or because of widespread intrahepatic recurrence. In the past two decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment modality and has attracted great interest because of its effectiveness and safety for small HCC (≤ 5.0 cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported a 3-year survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors are usually detected when they are small and PRFA causes the least deterioration of liver function in the patients. Our previous retrospective study demonstrated that RFA was comparable to re-resection for recurrent HCC, and our recent RCT showed that RFA combined with TACE is superior to RFA for HCC ≤7.0cm. So our hypothesis is that RFA combined with TACE is superior to re-resection for recurrent small HCC. The aim of this retrospective study is to compare the outcome of reresection with TACE+RFA for small recurrent HCC after partial hepatectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

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, 510060
        • Sun Yat-Sen University Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • minshan chen, 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:

  1. age 18 - 75 years;
  2. recurrence of HCC 12 months after initial hepatectomy;
  3. no other treatment received except for the initial hepatectomy;
  4. Single tumor≤5cm in diameter; or 2-3 lesions each ≤ 3.0 cm
  5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
  6. no severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3;
  7. Eastern Co-operative Oncology Group performance(ECOG) status 0 -1

Exclusion Criteria:

  1. the presence of vascular invasion or extrahepatic spread on imaging;
  2. a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
  3. an American Society of Anesthesiologists (ASA) score ≥ 3 -

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TACE+RFA
TACE was performed according to the following protocol: All patients underwent a distal super-selective catheterization of the hepatic arteries using a coaxial technique and micro-catheters (2.9 Fr, Terumo Corporation, Tokyo, Japan). Then, the same three chemotherapeutic agents at the same dosages were used throughout this study, regardless of tumor number and size. Hepatic artery infusion chemotherapy was performed using carboplatin 300 mg. After that, chemolipiodolization was performed using epirubicin 50 mg, and mitomycin C 8 mg mixed with 5 mL of lipiodol. If the territory of the chemolipiodolized artery did not show stagnant flow, pure lipiodol was then injected. RFA was performed after TACE in 2 months by using a commercially available system (RF 2000; Radio-Therapeutics Mountain View, CA), and a needle electrode with a 15 Ga insulated cannula with 10 hook-shaped expandable electrode tines with a diameter of 3.5 cm at expansion (LeVeen; RadioTherapeutics).
Procedure: TACE+RFA
TACE first, followed by RFA within 2 months
Active Comparator: re-resection
Re-resection was carried out under general anesthesia using a right subcostal incision with a midline extension. Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant and the possibility of a negative resection margin. We performed anatomical resection aiming at a resection margin of at least 1 cm. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 minutes and 5 minutes, respectively. Hemostasis of the raw liver surface was done with suturing and application of fibrin glue.
Procedure: re-resection
repeat hepatectomy for recurrent small HCC
Other Names:
  • repeat hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5 year
5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: 5 year
5 year

Other Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 30 days
30 days
Morbidity
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: minshan chen, M.D., Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

July 1, 2013

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

April 12, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Estimate)

April 16, 2013

Last Update Submitted That Met QC Criteria

April 12, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TACE+RFA VS. Re-resection
  • 5010 (the 5010 Foundation of Sun Yat-sen University)

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.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on TACE+RFA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe