Wang 2018a.
Methods | Study design: Randomised clinical trial Study duration: January 2013 to June 2016 Duration of follow‐up: 3 years Setting: Hospital |
Participants | Inclusion criteria: Diagnosed as HCC by biopsy and images; unsuitable for resection; with liver function of Child‐Pugh Class A or B; no history of radiotherapy or chemotherapy Exclusion criteria: Abnormal haematopoietic function; with serious immune, digestive or nervous system diseases; with no history of other tumours Age (mean ± SD, range): TACE + RFA: 56. 97 ± 7.49 years, 31‐69 years; TACE: 55.26 ± 7.82 years, 34‐68 years Male (n/total): TACE + RFA: 29/45; TACE alone: 30/45 Tumour diameter (mean ± SD, range): TACE + RFA: 5.17 ± 1.12 cm; TACE: 5.03 ± 1.21 cm Child‐Pugh Class (patients): Class A: TACE + RFA: 32; TACE: 30 Class B: TACE + RFA: 13; TACE: 15 |
Interventions | TACE + RFA group (n = 45): TACE: Chemotherapeutic drugs: 5‐fluorouracil 2 g and oxaliplatin 200 mg. Multiple sessions of TACE were performed, with an interval of 1‐1.5 months. RFA: The interval between TACE and RFA was 2 weeks. Output power of 60 w, ablation margin of 1 cm TACE group (n = 45): Chemotherapeutic drugs: 5‐fluorouracil 2 g and oxaliplatin 200 mg. Multiple sessions of TACE were performed, with an interval of 1‐1.5 months |
Outcomes | Tumour response, classified as complete response, partial response, stable disease, and progression, measured at 4 weeks after treatment 1‐, 2‐, and 3‐year survival rates Recurrence rate |
Notes | Country of study: China
Source of funding: Luohe City Medical Project (1400134) 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. |