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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02616926
• Other study ID #: 2015012
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2015
• Last updated: December 4, 2015
• Start date: December 2015
• Est. completion date: July 2021

Study information

• Verified date: December 2015
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Baogang Peng, MD
• Phone: 020-87755766-8214
• Email: pengbaogang[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 538
• Est. completion date: July 2021
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Hepatic resection
Anatomical surgical resection of the liver including the tumor. Make sure the resection margin is negative during the process.
• TACE
TACE will be performed according to the standard procedure of TACE and will be repeated every four months if needed
• RFA
RFA will be performed 1 week after TACE.

Locations

Country	Name	City	State
China	Department of Hepatic Surgery, First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Department of Hepatobiliary Surgery, Cancer Center of Sun-Yat Sen University	Guangzhou	Guangdong
China	Department of Hepatobiliary Surgery, Sun-Yat Sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

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 hepato — View 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 — View 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 — View 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	compare 3-year overall survival between the two arms	3 years	Yes
Secondary	disease free survival	compare 3-year disease free survival between the two arms	3 years	Yes