Du 2017.
Methods | Study design: Randomised clinical trial Study duration: December 2012 to December 2015 Duration of follow‐up: Not reported Setting: Hospital |
Participants | Inclusion criteria: Diagnosed as HCC by liver biopsy; the maximal tumour diameter ≥ 5 cm; single tumour Exclusion criteria: Portal vein was completely obstructed; serious portal hypertension Age (mean ± SD, range): TACE + RFA: 57.14 ± 5.27 years, 28‐73 years; TACE alone: 57.48 ± 3.71 years, 26‐71 years Male (n/total): TACE + RFA: 28/40; TACE alone: 27/40 Tumour diameter (mean ± SD): TACE + RFA: 8.27 ± 2.35 cm; TACE alone: 8.80 ± 2.57 cm Serum level of AFP: Abnormal: TACE + RFA: 38 patients; TACE alone: 36 patients Normal: TACE + RFA: 2 patients; TACE alone: 4 patients |
Interventions | TACE + RFA group (n = 40): TACE: Chemotherapeutic drugs: epirubicin 50‐60 mg RFA: Output power of 70‐90 W. Multiple sessions of RFA were performed with an interval of 1‐2 weeks. For patients with the tumour maximal diameter less than 10 cm, the total time per RFA treatment was 30‐60 minutes. For patients with the tumour maximal diameter ≥ 10 cm, the total time per RFA treatment was 80‐100 minutes. TACE group (n = 40): Chemotherapeutic drugs: epirubicin 50‐60 mg |
Outcomes | Tumour response: measured by image examinations at 6 months after treatment Clinical efficacy (serum level of ALT, TBIL, AFP, and tumour diameter) Adverse events |
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. |