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. 2019 Feb 16;2019(2):CD012244. doi: 10.1002/14651858.CD012244.pub2

Liao 2010.

Methods Study design: parallel randomised clinical trial
Study duration: November 2005 to November 2007
Duration of follow‐up: date of TACE therapy until the last follow‐up visit (or death) up to November 2009 (median 12 months; range 2–38 months)
Participants Country: China
Setting: inpatient, 1 centre
People with liver function Child‐Pugh class A or B; ECOG PS 0–2; no distant metastasis; no obvious myelosuppression or renal damage
Number: treatment group 24; control group 24
Mean age: treatment group 62 years; control group 63 years
Sex (M/F): treatment group 15/9; control group 14/10
Tumour size: treatment group 3.5–11 cm; control group 3.8–11.5 cm
Child‐Pugh class (A/B): treatment group 17/7; control group 17/7
Stage (III/IV): treatment group 18/6; control group 16/8
Interventions Control group: 3–5 courses of TACE with 1‐month interval. TACE comprised hepatic arterial infusion chemotherapy and hepatic artery embolisation. 5‐fluorouracil 1000–1250 mg; cisplatin 70–90 mg; adriamycin 50–60 mg; peripheral embolisation with iodine oil emulsion and central embolisation with gelfoam
Treatment group: 3–5 courses of TACE with 1‐month interval; 3‐DCRT delivered 1–2 weeks after the last course of TACE if liver function tests were normal. Radiotherapy: Varian23EX linear accelerator used to deliver 6 MV high‐energy X‐ray radiotherapy. Sum of radiation doses received by each participants ranged from 40 Gy to 66 Gy (median 55 Gy) with 2–2.5 Gy/day, radiation administered in 20–33 sessions
Outcomes According to RECIST, treatment efficacy divided into CR, PR, SD, and PD
 Response rate was the sum of CR+PR
  • 1‐ and 3‐year survival rates

  • Toxic effects

  • Death rate and cause

Notes Source of funding: Project of Quzhou Science and Technology Bureau
No information on the compliance and ITT/PP analysis
Attempted to contact the first author, without success
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomization was performed by drawing lots."
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported for all outcomes
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported for all outcomes
Incomplete outcome data (attrition bias) 
 All outcomes High risk There were postrandomisation dropouts and all relevant outcomes were reported for only 45 participants (i.e. 23 in treatment and 22 in control group).
Selective reporting (reporting bias) High risk 1 predefined outcome (serious adverse events) not reported. Protocol not available
Other bias Low risk No other potential source of bias identified, baseline characteristics comparable