ChiCTR‐IOR‐16007915.

Study name	Transarterial chemoembolization (TACE) with or without sequential cryoablation in hepatocellular carcinoma of BCLC B: a multicentral randomised controlled trial
Methods	Interventional study
Participants	Inclusion criteria: 1. CT, MRI, and AFP combined with clinical or pathological diagnosis of hepatocellular carcinoma 2. Prior informed consent; be able to follow the visit/treatment rules according to the research programmes 3. Generally in good condition, adequate bone marrow, liver and renal function 4. ECOG Performance Status of 0‐2 5. Advanced stage HCC/BCLC B stage 6. Hepatitis B history or HBsAg positive 7. Patients without previous surgery, local‐regional therapies (radiofrequency ablation, etc.), or liver transplantation 8. Aged 18 to 65 years 9. Child Pugh class A/B (=< 7) 10. Baseline laboratory tests meeting the following criteria: platelet count >= 100 * 10 ^ 9/L; ALT and AST < 3 * upper limit of normal; BUN and creatinine < 1.5 * upper limit of normal; INR < 1.5, or PT < 4 seconds above control. ALB >= 30g/L; total bilirubin =< 34 mmol/L Exclusion criteria： 1. Pregnant or lactating women 2. Extrahepatic metastasis, or tumour thrombosis invasive venous system 3. Any contraindications for hepatic embolisation procedures (known renal failure/insufficiency requiring hemo‐or peritoneal dialysis) 4. Patients with prior malignancy were ineligible for the study, with the exception of those who had been disease‐free for longer than 5 years 5. Patients with liver transplantation
Interventions	Group A: Transarterial chemoembolisation Group B: Transarterial chemoembolisation (TACE) with sequential cryoablation
Outcomes	3‐year overall survival rate Postoperative complication Time to progression Distant metastasis rate
Starting date	2016‐04‐01
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