Hepatic Resection Versus TACE+RFA for BCLC Stage B Hepatocellular Carcinoma

December 4, 2015 updated by: Baogang Peng, First Affiliated Hospital, Sun Yat-Sen University

Hepatic Resection Versus Transarterial Chemoembolization Plus Radiofrequency Ablation for Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world. For patients with intermediate HCC (BCLC stage B), transarterial chemoembolization (TACE) has been recommended as the standard therapy in many clinical practice guidelines. The combination of TACE and radiofrequency ablation (RFA) has also been reported as an effective treatment. However, more and more retrospective studies have reported better therapeutic efficacy of hepatic resection than TACE for intermediate HCC. The purpose of this study was to compare the efficacy of hepatic resection versus TACE+RFA for the treatment of intermediate HCC through prospective randomized clinical trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Barcelona Clinic Liver Cancer (BCLC) staging system is the most widely used stage classification for HCC management. For patients with intermediate HCC, palliative treatment transarterial chemoembolization (TACE) was recommended as first choice treatment. However, this recommendation remains controversial. The advice for diagnosis and treatment of HCC from former Chinese Ministry of Health indicated that BCLC may not be suitable in China as most HCC patients were found in intermediate or advanced stage. In recent years, more and more studies declared surgical resection as a better choice for HCC patients in BCLC stage B. However, lack of randomization, small sample size and lack of prospective studies limit the strength of evidence.

To solve this dilemma, a prospective randomized control study was performed to compare the efficacy (1-, 2-, 3-year survival) between surgical resection group and TACE plus radiofrequency ablation group in HCC patients in intermediate stage. This study will provide powerful evidence regarding the better treatment option for HCC patients in BCLC B stage, which will benefit the treatment efficacy of HCC patients in BCLC B stage.

Study Type

Interventional

Enrollment (Anticipated)

538

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Department of Hepatobiliary Surgery, Cancer Center of Sun-Yat Sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Department of Hepatobiliary Surgery, Sun-Yat Sen Memorial Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Department of Hepatic Surgery, First Affiliated Hospital, Sun Yat-Sen University
        • 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Hepatocellular Carcinoma diagnosed by biopsy or imaging criteria (CT/MRI) and AFP
  2. Signed informed consent before registration on study
  3. Child-Pugh class A or B
  4. Eastern Cooperative Oncology Group Performance status between 0 and 2.
  5. BCLC stage B ( diameter of the single tumor ≥5cm or number of tumors ≥3)
  6. Hepatitis B history or HBsAg positive
  7. Age between 18 and 65 years
  8. No previous treatment
  9. Laboratory examination test: Platelet count ≥100×109/L; ALT/AST ≤ 3 x ULN; Cr1.5≤ x ULN; INR < 1.5 or PT< ULN +4s; Alb≥30g/L; Tbil≤34mmol/L
  10. For patients in Hepatic resection group: radical surgery will be performed: (1) No segmental, lobar or main portal vein and bile duct thrombosis; (2) no lymph nodes metastasis; (3) no extra hepatic metastasis.

Exclusion Criteria:

  1. cachexia or poor physical condition;
  2. pregnant or HCG positive;
  3. Portal vein and bile duct thrombosis or with extra hepatic metastasis.
  4. Uncontrolled or refractory ascites or history of hepatic encephalopathy
  5. Severe heart, brain or kidney diseases
  6. hemophilia or patients with coumarin derivative therapy.
  7. .history of organ transplantation or mental disease.
  8. Be allergic to adriamycin, lobaplatin, mitomycin or 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hepatic resection

Hepatic resection is performed as a primary treatment for hepatocellular carcinoma.

Intervention: Hepatic resection
Procedure: Hepatic resection
Anatomical surgical resection of the liver including the tumor. Make sure the resection margin is negative during the process.
Other Names:
  • hepatectomy
Active Comparator: TACE + RFA

TACE is performed as a primary treatment for hepatocellular carcinoma. RFA will be performed two weeks later if necessary.

Intervention: TACE; RFA
Procedure: TACE
TACE will be performed according to the standard procedure of TACE and will be repeated every four months if needed
Other Names:
  • transcatheter arterial chemoembolization
Procedure: RFA
RFA will be performed 1 week after TACE.
Other Names:
  • radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 years
compare 3-year overall survival between the two arms
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free survival
Time Frame: 3 years
compare 3-year disease free survival between the two arms
3 years

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborators

Sun Yat-sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Baogang Peng, MD, First Affiliated Hospital of Sun Yat-sen University

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

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

December 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

October 25, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

November 30, 2015

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015012

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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