NCT02616926

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
538

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

December 7, 2015

Status Verified

December 1, 2015

Enrollment Period

2.6 years

First QC Date

October 25, 2015

Last Update Submit

December 4, 2015

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomahepatectomytransarterial chemoembolizationradiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • overall survival

    compare 3-year overall survival between the two arms

    3 years

Secondary Outcomes (1)

  • disease free survival

    3 years

Study Arms (2)

Hepatic resection

EXPERIMENTAL

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

Procedure: Hepatic resection

TACE + RFA

ACTIVE COMPARATOR

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

Procedure: TACEProcedure: RFA

Interventions

Hepatic resectionPROCEDURE

Anatomical surgical resection of the liver including the tumor. Make sure the resection margin is negative during the process.

Also known as: hepatectomy
Hepatic resection
TACEPROCEDURE

TACE will be performed according to the standard procedure of TACE and will be repeated every four months if needed

Also known as: transcatheter arterial chemoembolization
TACE + RFA
RFAPROCEDURE

RFA will be performed 1 week after TACE.

Also known as: radiofrequency ablation
TACE + RFA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hepatocellular Carcinoma diagnosed by biopsy or imaging criteria (CT/MRI) and AFP
  • Signed informed consent before registration on study
  • Child-Pugh class A or B
  • Eastern Cooperative Oncology Group Performance status between 0 and 2.
  • BCLC stage B ( diameter of the single tumor ≥5cm or number of tumors ≥3)
  • Hepatitis B history or HBsAg positive
  • Age between 18 and 65 years
  • No previous treatment
  • 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
  • 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.

You may not qualify if:

  • cachexia or poor physical condition;
  • pregnant or HCG positive;
  • Portal vein and bile duct thrombosis or with extra hepatic metastasis.
  • Uncontrolled or refractory ascites or history of hepatic encephalopathy
  • Severe heart, brain or kidney diseases
  • hemophilia or patients with coumarin derivative therapy.
  • history of organ transplantation or mental disease.
  • Be allergic to adriamycin, lobaplatin, mitomycin or iodized oil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Hepatobiliary Surgery, Cancer Center of Sun-Yat Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Department of Hepatobiliary Surgery, Sun-Yat Sen Memorial Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Department of Hepatic Surgery, First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (4)

  • Torzilli G, Belghiti J, Kokudo N, Takayama T, Capussotti L, Nuzzo G, Vauthey JN, Choti MA, De Santibanes E, Donadon M, Morenghi E, Makuuchi M. A snapshot of the effective indications and results of surgery for hepatocellular carcinoma in tertiary referral centers: is it adherent to the EASL/AASLD recommendations?: an observational study of the HCC East-West study group. Ann Surg. 2013 May;257(5):929-37. doi: 10.1097/SLA.0b013e31828329b8.

    PMID: 23426336RESULT

  • Zhong JH, Xiang BD, Gong WF, Ke Y, Mo QG, Ma L, Liu X, Li LQ. Comparison of long-term survival of patients with BCLC stage B hepatocellular carcinoma after liver resection or transarterial chemoembolization. PLoS One. 2013 Jul 9;8(7):e68193. doi: 10.1371/journal.pone.0068193. Print 2013.

    PMID: 23874536RESULT

  • Ng KK, Vauthey JN, Pawlik TM, Lauwers GY, Regimbeau JM, Belghiti J, Ikai I, Yamaoka Y, Curley SA, Nagorney DM, Ng IO, Fan ST, Poon RT; International Cooperative Study Group on Hepatocellular Carcinoma. Is hepatic resection for large or multinodular hepatocellular carcinoma justified? Results from a multi-institutional database. Ann Surg Oncol. 2005 May;12(5):364-73. doi: 10.1245/ASO.2005.06.004. Epub 2005 Mar 31.

    PMID: 15915370RESULT

  • Peng ZW, Zhang YJ, Chen MS, Xu L, Liang HH, Lin XJ, Guo RP, Zhang YQ, Lau WY. Radiofrequency ablation with or without transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma: a prospective randomized trial. J Clin Oncol. 2013 Feb 1;31(4):426-32. doi: 10.1200/JCO.2012.42.9936. Epub 2012 Dec 26.

    PMID: 23269991RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

HepatectomyRadiofrequency Ablation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeRadiofrequency TherapyTherapeuticsAblation Techniques

Study Officials

  • Baogang Peng, MD

    First Affiliated Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Baogang Peng, MD

CONTACT

020-87755766-8214pengbaogang@medmail.com.cn

Shunli Shen, MD

CONTACT

020-87755766-8214shunlishen@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Hepatic Surgery

Study Record Dates

First Submitted

October 25, 2015

First Posted

November 30, 2015

Study Start

December 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2021

Last Updated

December 7, 2015

Record last verified: 2015-12

Locations

CN(3)