Clinical trial NCT02616926: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
hepatectomy
transarterial chemoembolization
radiofrequency ablation
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2015-11-30
Enrollment: 538
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: 3 years
Secondary outcomes:
measure: disease free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hepatobiliary Surgery, Cancer Center of Sun-Yat Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Department of Hepatobiliary Surgery, Sun-Yat Sen Memorial Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Department of Hepatic Surgery, First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital of Sun Yat-Sen University
name: Baogang Peng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.