Table 1.
Demographics and clinical characteristics.
| Characteristics | PLENTY (n=10) | CONTROL (n=11) | P |
|---|---|---|---|
| Age at randomization, years | 57.5 (38–68) | 51 (38–66) | 0.440 |
| Sex | 0.944 | ||
| Male | 9 (90.0%) | 10 (90.1%) | |
| Female | 1 (10.0%) | 1 (9.1%) | |
| ECOG performance status | 0.329 | ||
| 0 | 10 (100%) | 10 (90.1%) | |
| 1 | 0 (0) | 1 (9.1%) | |
| HBV background | 10 (100%) | 11 (100%) | / |
| Maximum tumor size (cm) | 7.01 (1.655–16.94) | 7.5 (2.3–14.5) | 0.446 |
| Number of lesions | 3.5 (1–23) | 3 (1–12) | 0.753 |
| PVTT | 0.835 | ||
| Vp0 | 5 (50.0%) | 5 (45.5%) | |
| Vp1-3 | 5 (50.0%) | 6 (54.5%) | |
| BCLC stage | 0.528 | ||
| B | 5 (50%) | 4 (36.4%) | |
| C | 5 (50%) | 7 (63.6%) | |
| Alpha-fetoprotein | 0.466 | ||
| ≤400 ng/ml | 3 (30.0%) | 5 (45.5%) | |
| >400 ng/ml | 7 (70.0%) | 6 (54.5%) | |
| Des-γ-carboxyprothrombin | 0.890 | ||
| ≤400 mAU/ml | 7 (70.0%) | 8 (72.7%) | |
| >400 mAU/ml | 3 (30.0%) | 3 (27.3%) | |
| ALT (U/l) | 47 (23–88) | 53 (21–111) | 0.841 |
| AST (U/l) | 72 (21–99) | 55 (22–162) | 0.479 |
| Child-Pugh class | 0.217 | ||
| A | 8 (80.0%) | 6 (54.5%) | |
| B | 2 (20.0%) | 5 (45.5%) | |
| Waiting time (Day) | 114 (89–256) | 33 (15–63) | 0.001 |
| Waiting list mortality | 0.329 | ||
| No | 10 (100%) | 10 (90.1%) | |
| Yes | 0 (0) | 1 (9.1%) | |
| Treatment cycles | 4 (2–5) | / | / |
| Washout period (Day) | 60.5 (25–193) | / | / |
Data are n (%) or median (range).
ALT, alanine transaminase; AST, aspartate transaminase; BCLC, Barcelona Clinic Liver Cancer; ECOG, Eastern Cooperative Oncology Group; HBV, Hepatitis B Virus; LRT, loco-regional therapy; PVTT, portal vein tumor thrombus; TB, total bilirubin.