Table 1.
Baseline characteristics of the study population by treatment.
| Variables, n (%) or mean ± S.D | Total, N=90 | Nivolumab group, N=32 | Regorafenib group, N = 58 | P-value |
|---|---|---|---|---|
| Age (years) | 63 ± 10.4 | 62.2 ± 10.1 | 63.4 ± 10.7 | 0.601 |
| Male sex (%) | 67 (74.4) | 23 (71.9) | 44 (75.9) | 0.678 |
| HCC etiology | 0.226 | |||
| HBV | 46 (51) | 18 (56.3) | 28 (48.3) | |
| HCV | 34 (37.8) | 11 (34.4) | 23 (39.7) | |
| HBV+HCV | 3 (3.2) | 2 (6.2) | 1 (1.7) | |
| Non-HBV, non-HCV | 7 (7.8) | 1 (3.1) | 6 (10.3) | |
| Child-Pugh class | 0.01 | |||
| A | 80 (88.9) | 25 (78.1) | 56 (96.6) | |
| B | 10 (11.1) | 7 (21.9) | 2 (3.4) | |
| BCLC stage | 0.989 | |||
| B | 14 (15.6) | 5 (15.6) | 9 (15.5) | |
| C | 76 (84.4) | 27 (84.4) | 49 (84.5) | |
| EHM | 50 (55.5) | 18 (56.3) | 32 (55.2) | 0.922 |
| Lung | 22 (24.4) | 9 (28.1) | 13 (22.4) | |
| Lymph node | 12 (13.3) | 4 (12.5) | 8 (13.8) | |
| Bone | 10 (11.1) | 4 (12.5) | 6 (10.3) | |
| Others | 10 (11.1) | 1 (3.1) | 9 (15.5) | |
| MVI* | 37 (41.1) | 14 (43.8) | 23 (39.7) | 0.705 |
| VP3 | 20 (22.2) | 6 (18.8) | 14 (24.1) | |
| VP4 | 17 (18.9) | 8 (25) | 9 (15.5) | |
| Tumor size ≥ 6 cm, | 18 (20) | 10 (33.3) | 8 (13.8) | 0.031 |
| AST, U/L | 82.2 ± 75.4 | 104.6 ± 89.5 | 69.9 ± 63.9 | 0.058 |
| ALT, U/L | 59.3 ± 45.3 | 67.9 ± 45.8 | 54.5 ± 44.7 | 0.184 |
| Albumin, g/dL | 3.8 ± 0.5 | 3.6 ± 0.6 | 3.9 ± 0.4 | 0.025 |
| Total bilirubin, mg/dL | 1.2 ± 0.8 | 1.5 ± 1.1 | 1.1 ± 0.4 | 0.043 |
| Platelet count, ×109/L | 142.8 ± 82.8 | 156.1 ± 99.8 | 135.7 ± 71.9 | 0.32 |
| INR | 1.06 ± 0.19 | 1.03 ± 0.3 | 1.07 ± 0.9 | 0.403 |
| AFP, ng/mL | 7177.3 ± 18321 | 8348.4 ± 21446 | 6531.2 ± 16725 | 0.677 |
| Duration of Sorafenib | 2.87 ± 1.99 | 4.90 ± 2.89 | 2.75 ± 1.86 | <0.001 |
AFP, alpha fetoprotein; ALBI grade, albumin-biliribin grade; ALT, alanine transaminase; AST, aspartate aminotransferase; BCLC, Barcellola Clinic Liver Cancer; CI, confidence interval; EHM, extra-hepatic metastasis; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; INR, international ratio; MVI, macro-vascular invasion.
*VP3: Tumor invasion into left portal vein or right portal vein; VP4: Tumor invasion into bilateral portal vein and/or main portal vein.