Yu 2019.
Methods | Study design: Randomised clinical trial Study duration: May 2013 to May 2016 Duration of follow‐up: 2 years Setting: Hospital |
Participants | Inclusion criteria: Diagnosed as HCC by biopsy or images; with liver function of Child‐Pugh Class A or B; tumour diameter ≥ 5 cm Exclusion criteria: With abnormal haematopoietic function; with portal vein tumour thrombus or extrahepatic metastasis; with abnormal renal or cardiac function Age (mean ± SD): TACE + RFA: 55.9 ± 4.3 years; TACE alone: 55.6 ± 4.1 years Male (n/total): TACE + RFA: 23/34; TACE alone: 22/34 Tumour diameter (mean ± SD): TACE + RFA: 6.23 ± 0.35 cm; TACE: 6.2 ± 0.35 cm Child‐Pugh Class (patients): Class A: TACE + RFA: 17; TACE: 15 Class B: TACE + RFA: 17; TACE: 19 |
Interventions | TACE + RFA group (n = 34): TACE: Chemotherapeutic drugs: theprubicin 20‐60 mg and oxaliplatin 60‐100 mg. Multiple sessions of TACE can be performed for each patient, with an interval of 4‐6 weeks RFA: The interval between TACE and RFA was 1‐2 weeks. LDRF‐20S ablation system. With tumour margin of 0.5‐1 cm TACE group (n = 34): Chemotherapeutic drugs: theprubicin 20‐60 mg and oxaliplatin 60‐100 mg Multiple sessions of TACE can be performed for each patient, with an interval of 4‐6 weeks. |
Outcomes | Tumour response, according to mRECIST criteria Adverse events 1‐ and 2‐year survival rates |
Notes | Country of study: China
Source of funding: None 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. |