| Methods |
Randomised.
Generation of the allocation sequence: not clear.
Allocation concealment: sealed envelopes.
Blinding: no.
Follow‐up: adequate.
Intention‐to‐treat analysis: yes.
Sample size calculations: no. |
| Participants |
57 patients without residual disease 1 month after curative resection, Child's grade A or B. |
| Interventions |
1. Surgery: 27 patients, major hepatectomy (25%) and minor hepatectomy (75%).
2. Adjuvant: 29 patients, one month postoperative hepatic arterial infusion chemotherapy with epirubicin 40 mg/m2, then IV epirubicin 40 mg/m2 every three months for two years. Additionally, oral 1‐hexylcarbamoyl 5‐fluorouracil (HCFU) 300mg daily at one month postoperative for 24 months. |
| Outcomes |
Follow‐up every two weeks for first six months postoperative, thereafter at monthly intervals by US, CT, and angiography.
1. Survival: survival curves.
2. Disease‐free survival: survival curves. |
| Notes |
Groups comparable at baseline.
Radicality of resection judged by intraoperative and postoperative imaging, histopathology (margin >= 5mm).
Repeat TACE or resection on patients with recurrence.
Severe adverse events caused three withdrawals from adjuvant group (atrial fibrillation, severe appetite loss (2)), seven patients with minor side‐effects (nausea, vomiting, alopecia).
HR not reported. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
