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

Primary Purpose

Hepatocellular Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Hepatic resection

TACE

RFA

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, hepatectomy, transarterial chemoembolization, radiofrequency ablation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Department of Hepatobiliary Surgery, Cancer Center of Sun-Yat Sen UniversityRecruiting
Department of Hepatobiliary Surgery, Sun-Yat Sen Memorial HospitalRecruiting
Department of Hepatic Surgery, First Affiliated Hospital, Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hepatic resection

TACE + RFA

Arm Description

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

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

Outcomes

Primary Outcome Measures

overall survival

compare 3-year overall survival between the two arms

Secondary Outcome Measures

disease free survival

compare 3-year disease free survival between the two arms

Full Information

NCT ID

NCT02616926

First Posted

October 25, 2015

Last Updated

December 4, 2015

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02616926

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, hepatectomy, transarterial chemoembolization, radiofrequency ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

538 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hepatic resection

Arm Type

Experimental

Arm Description

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

Arm Title

TACE + RFA

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Hepatic resection

Other Intervention Name(s)

hepatectomy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

TACE

Other Intervention Name(s)

transcatheter arterial chemoembolization

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

RFA

Other Intervention Name(s)

radiofrequency ablation

Intervention Description

RFA will be performed 1 week after TACE.

Primary Outcome Measure Information:

Title

overall survival

Description

compare 3-year overall survival between the two arms

Time Frame

3 years

Secondary Outcome Measure Information:

Title

disease free survival

Description

compare 3-year disease free survival between the two arms

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Baogang Peng, MD

Phone

020-87755766-8214

pengbaogang@medmail.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Shunli Shen, MD

Phone

020-87755766-8214

shunlishen@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baogang Peng, MD

Organizational Affiliation

First Affiliated Hospital of Sun Yat-Sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunfei Yuan, M.D

Phone

8602087343118

yuanyf@mail.sysu.edu.cn

Facility Name

Department of Hepatobiliary Surgery, Sun-Yat Sen Memorial Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yajin Chen, M.D

Phone

8602034071169

cyj0509@126.com

Facility Name

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

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Baogang Peng, M.D

Phone

8687755766

Ext

8214

pengbaogang@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Shunli Shen, M.D

Phone

8687755766

Ext

8214

shunlishen@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

23426336

Citation

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.

Results Reference

result

PubMed Identifier

23874536

Citation

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.

Results Reference

result

PubMed Identifier

15915370

Citation

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.

Results Reference

result

PubMed Identifier

23269991

Citation

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.

Results Reference

result

Learn more about this trial

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

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