Takayama 2000.
| Methods | Randomised. Generation of the allocation sequence: used permuted blocks. Allocation concealment: not clear. Blinding: yes. Radiologists were blinded. Follow‐up: adequate. Intention‐to‐treat analysis: yes. Sample size calculations: yes. | |
| Participants | 155 patients aged 18 to 80 years, with histologically confirmed hepatocellular carcinoma and who underwent curative resection. | |
| Interventions | 1. Surgery: 76 patients were randomised but only 74 met the inclusion criteria. 2. Adjuvant: 79 were randomised but only 76 met the inclusion criteria. Patients received autologous lymphocytes (immunotherapy) intravenously at weeks 2, 3, 4, 12 and 24 weeks after surgery. This schedule was designed to transfer sufficient cells. |
|
| Outcomes | 1. Time to first recurrence. 2. Recurrence free survival. 3. Disease‐free survival. 4. Overall survival. | |
| Notes | Groups were similar at baseline. The treatment was given not later than 1 week after surgery. 62 adverse events developed in 45 patients, all of which were grade 1 or 2 and self limiting. The most common was fever (47%) followed by headache (4%), nausea (4%), dizziness (1%), itching (1%) and tachycardia (1%). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |