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

NCT ID: NCT02616926

Last Updated: 2015-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

538 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hepatic resection

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

Intervention: Hepatic resection

Group Type EXPERIMENTAL

Hepatic resection

Intervention Type PROCEDURE

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

TACE + RFA

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

Intervention: TACE; RFA

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

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

RFA

Intervention Type PROCEDURE

RFA will be performed 1 week after TACE.

Interventions

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Hepatic resection

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

Intervention Type PROCEDURE

TACE

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

Intervention Type PROCEDURE

RFA

RFA will be performed 1 week after TACE.

Intervention Type PROCEDURE

Other Intervention Names

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hepatectomy transcatheter arterial chemoembolization radiofrequency ablation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Baogang Peng

Director, Department of Hepatic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baogang Peng, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Sun Yat-Sen University

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Department of Hepatobiliary Surgery, Sun-Yat Sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Baogang Peng, MD

Role: CONTACT

[email protected]
020-87755766-8214

Shunli Shen, MD

Role: CONTACT

[email protected]
020-87755766-8214

Facility Contacts

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Yunfei Yuan, M.D

Role: primary

[email protected]
8602087343118

Yajin Chen, M.D

Role: primary

[email protected]
8602034071169

Baogang Peng, M.D

Role: primary

[email protected]
8687755766 ext. 8214

Shunli Shen, M.D

Role: backup

[email protected]
8687755766 ext. 8214

References

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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.

Reference Type RESULT
PMID: 23426336 (View on PubMed)

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.

Reference Type RESULT
PMID: 23874536 (View on PubMed)

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.

Reference Type RESULT
PMID: 15915370 (View on PubMed)

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.

Reference Type RESULT
PMID: 23269991 (View on PubMed)

Other Identifiers

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2015012

Identifier Type: -

Identifier Source: org_study_id