Skip to main content
. 2017 Mar 10;2017(3):CD011649. doi: 10.1002/14651858.CD011649.pub2

Bruix 2012.

Study characteristics
Methods Randomised clinical trial.
Participants Country: multi‐centric, international.
Number randomised: 105.
Post‐randomisation dropouts: 0 (0%).
Revised sample size: 105.
Mean age: 69 years.
Females: 16 (15.2%).
Cirrhosis: not stated.
Portal hypertension: not stated.
Viral aetiology: 39 (37.1%).
Immunotherapy/antiviral adjuvant therapy: not stated.
Mean follow‐up period (for all groups): not stated.
Criteria for intermediate‐stage HCC and other inclusion criteria:
  • Authors clearly stated BCLC stage B but no further details available in the manuscript.

Interventions Participants were randomly assigned to 2 groups.
Group 1: sorafenib (n = 54).
Further details: chemotherapy: sorafenib 400 mg twice daily until radiological or symptomatic progression.
Group 2: placebo (n = 51).
Outcomes Mortality.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Study randomization was centralized, and assignment to study groups was conducted by computer to achieve a balance between the two groups".
Allocation concealment (selection bias) Low risk Quote: "Study randomization was centralized, and assignment to study groups was conducted by computer to achieve a balance between the two groups".
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "phase 3, double‐blind, placebo‐controlled trial…All eligible patients were randomly assigned in a 1:1 ratio to receive continuous oral treatment with either 400 mg of sorafenib (consisting of two 200‐mg tablets) twice daily or matching placebo".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "phase 3, double‐blind, placebo‐controlled trial…All eligible patients were randomly assigned in a 1:1 ratio to receive continuous oral treatment with either 400 mg of sorafenib (consisting of two 200‐mg tablets) twice daily or matching placebo".
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: there were no post‐randomisation dropouts.
Selective reporting (reporting bias) High risk Comment: morbidity was not reported.
For‐profit bias High risk Quote: "The study was designed by Bayer HealthCare Pharmaceuticals in conjunction with the principal academic investigators".
Other bias Low risk Comment: no other bias noted.