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. 2022 Jan 4;2022(1):CD013345. doi: 10.1002/14651858.CD013345.pub2

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.