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Hepatocellular CarcinomaNCT02616926

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

A study testing Hepatic resection, TACE and RFA in people with Hepatocellular Carcinoma, run by First Affiliated Hospital, Sun Yat-Sen University at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Hepatic resection, TACE and RFA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
538 participants
Where
3 sitesChina
Study dates
Dec 2015to Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Baogang Peng, MD contact

020-87755766-8214

pengbaogang@medmail.com.cn

Shunli Shen, MD contact

020-87755766-8214

shunlishen@163.com

China3 sites, 3 recruiting

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

    Guangzhou, Guangdong, 510000

    Yunfei Yuan, M.D, 8602087343118, yuanyf@mail.sysu.edu.cn

    Recruiting

  • Department of Hepatobiliary Surgery, Sun-Yat Sen Memorial Hospital

    Guangzhou, Guangdong, 510000

    Yajin Chen, M.D, 8602034071169, cyj0509@126.com

    Recruiting

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

    Guangzhou, Guangdong, 510080

    Baogang Peng, M.D, 8687755766 ext. 8214, pengbaogang@medmail.com.cn

    Shunli Shen, M.D, 8687755766 ext. 8214, shunlishen@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Hepatic resection, TACE, RFA
Keywords
hepatocellular carcinoma, hepatectomy, transarterial chemoembolization, radiofrequency ablation
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hepatic resectionProcedure or surgery

    Also called hepatectomy

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

  • TACEProcedure or surgery

    Also called transcatheter arterial chemoembolization

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

  • RFAProcedure or surgery

    Also called radiofrequency ablation

    RFA will be performed 1 week after TACE.

Study groups in NCT02616926
Study groupRoleWhat they receive
Hepatic resectionExperimentalHepatic resection is performed as a primary treatment for hepatocellular carcinoma. Intervention: Hepatic resection
Receives: Procedure: Hepatic resection
TACE + RFAActive comparatorTACE is performed as a primary treatment for hepatocellular carcinoma. RFA will be performed two weeks later if necessary. Intervention: TACE; RFA
Receives: Procedure: TACE; Procedure: RFA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    compare 3-year overall survival between the two arms

    Measured: 3 years

Secondary outcomes (1)

  1. disease free survival

    compare 3-year disease free survival between the two arms

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
538 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02616926
Sponsor's protocol ID
2015012
Status last verified
Dec 2015
First submitted
25 Oct 2015
Last updated
7 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23426336

  • 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.

    PubMed 23874536

  • 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.

    PubMed 15915370

  • 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.

    PubMed 23269991

Questions about this trial

What is this clinical trial studying?

A study testing Hepatic resection, TACE and RFA in people with Hepatocellular Carcinoma, run by First Affiliated Hospital, Sun Yat-Sen University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Baogang Peng, MD (020-87755766-8214, pengbaogang@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02616926, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.

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