Xiong 2017.
Methods | Study design: Randomised clinical trial Study duration: February 2013 to January 2014 Duration of follow‐up: 3 years Setting: Hospital |
Participants | Inclusion criteria: diagnosed in line with the Criteria for Clinical Diagnosis of Primary Hepatic Carcinoma; they were diagnosed as having PHC, as demonstrated by serum alpha fetoprotein (AFP), CT or MRI; the Karnofsky Performance Status score ≥ 70; the Child‐Pugh scores or TNM stages of liver function were accurate; no previous systemic chemotherapy or radiotherapy. Exclusion criteria: with obvious hepatic arteriovenous fistula; had hepatic tumour which exceeded 70% of the volume of the liver; had obvious cachexia, jaundice, ascites or distant metastasis or a contraindication to chemotherapy Age (mean ± SD): TACE + RFA: 59.45 ± 5.34 years; TACE alone: 60.06 ± 5.41 years Male (n/total): TACE + RFA: 21/37; TACE alone: 24/37 Tumour diameter (mean ± SD, range): TACE + RFA: 5.08 ± 0.84 cm; TACE: 5.09 ± 0.86cm TNM stage (patients): StageⅠ: TACE+RFA: 11; TACE: 13 StageⅡ: TACE+RFA: 18; TACE: 19 StageⅢ: TACE+RFA: 8; TACE: 5 Child‐Pugh Class (patients): Class A: TACE + RFA: 25; TACE: 23 Class B: TACE + RFA: 12; TACE: 14 |
Interventions | TACE + RFA group (n = 37): The procedures of RFA were initiated at 15 d after TACE. The electrode was inserted into the tumour tissue under the guidance of CT, with the ablation power at 60 W for 10‐15 min. Single needle ablation was administered for 1‐3 bulbous focus, bilateral focal ablation for 4‐6 bulbous focus, and fractional ablation for patients with poor toleration. The RFA range can be extended to 1 cm inside the normal tissues to ensure full ablation. TACE group (n = 37): A catheter was inserted into the feeding artery, into which nonionic contrast agent lipiodol (5 mL), 5‐fluorouracil (2 g), and oxaliplatin (200 mg) were injected. |
Outcomes | Serum level of GGT and AFP Clinical response, according to RECIST criteria, measured at 3 years after treatment Tumour necrosis Recurrence and survival at 3‐year 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. |