Zhuang 2016.
Methods | Study design: Randomised clinical trial Study duration: November 2014 to April 2016 Duration of follow‐up: 2 years Setting: Hospital |
Participants | Inclusion criteria: Diagnosed as HCC; with liver function of Child‐Pugh Class A or B; with normal renal function; life expectancy > 3 months Age (mean, range): 63 years, 34‐80 years Male (n/total): 54/70 |
Interventions | TACE + cryoablation group (n = 35): TACE: Chemotherapeutic drugs: cisplatin 20‐50 mg and adriamycin 10‐40 mg Cryoablation: The interval between TACE and RFA was 2‐4 weeks. Multiple sessions of cryoablation can be performed with an interval of 4‐6 weeks. TACE group (n = 35): Chemotherapeutic drugs: cisplatin 20‐50 mg and adriamycin 10‐40 mg |
Outcomes | 1‐month, 6‐month, 1‐year, and 2‐year response rate, measured by CT or DSA (DSA: digital subtraction angiography) |
Notes | Country of study: China
Source of funding: Guangdong Province Science Project There was insufficient information available to satisfactorily determine the method of randomisation and the study data could not be verified. We have attempted to contact the study authors for more information, but so far, we have not been successful in doing this. |
AFP: alpha foetoprotein ALT: alanine aminotransferase BCLC B: Barcelona Clinic Liver Cancer Stage B (Intermediate Stage) CA199: carbohydrate antigen 19‐9 CEA: carcinoembryonic antigen CD(3+/4+/8+): lymphocytes CD3‐CD4‐CD8 ‐ whole blood (test) CT: computed tomography DBIL: direct bilirubin DSA: digital subtraction angiography ECOG: Eastern Cooperative Oncology Group ELISA: enzyme‐linked immunosorbent assay GGT: gamma‐glutamyl transferase HCC: hepatocellular carcinoma HIFU: high‐intensity focused ultrasound KPS: Karnofsky score mRECIST: modified Response Evaluation Criteria in Solid Tumors (guideline) MMP: matrix metalloproteinase MRI: magnetic resonance imaging MTI‐5DT: a tumor microwave therapy system MWA: microwave ablation NK: natural killer (cells) PET: positron emission tomography PHC: primary hepatic carcinoma PVTT: portal vein tumour trombosis QOL: quality of life RFA: radiofrequency ablation RFG(‐4): RET fused gene (RFG) SD: standard deviation SSC(‐Ag): squamous cell carcinoma TACE: transcatheter arterial chemoembolisation TBIL: total bilirubin (test) TGF‐β1: transforming growth factor beta 1 TNF‐α: tumour necrosis factor alpha TNM: Classification of Malignant Tumors standard for classifying the extent of spread of cancer (T: size or direct extent of the primary tumour; N: degree of spread to regional lymph nodes; M: presence of distant metastasis) VEGF: vascular endothelial growth factor yGT: gamma‐glutamyl transpeptidase (y‐GT) WHO: World Health Organization