Hepatic Resection Versus TACE+RFA for BCLC 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.

Sex

All

Minimum age

18 Years

Maximum age

65 Years

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

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