Table 1.
Baseline Patient Characteristics at Initiation of Second-Line Treatment
| Characteristic | Rego-Sintilimab Group (N = 58) | Regorafenib Group (N = 55) | P value |
|---|---|---|---|
| Male | 51 (87.9) | 50 (90.9) | 0.608 |
| Age (years) | 54 (41–62) | 51 (47–63) | 0.776 |
| ECOG score 1 | 23 (39.7) | 28 (50.9) | 0.230 |
| Positive for HBsAg | 48 (82.8) | 49 (89.1) | 0.335 |
| Child-Pugh B | 21 (36.2) | 20 (36.4) | 0.986 |
| Presence of ascites | 14 (24.1) | 13 (23.6) | 0.950 |
| Tumor diameter (cm) | 6.4 (4.3–9.5) | 5.5 (4.3–8.5) | 0.531 |
| Tumor size >5 cm | 40 (69.0) | 34 (61.8) | 0.424 |
| >3 intrahepatic tumors | 42 (72.4) | 41 (74.5) | 0.798 |
| Macrovascular invasion | 40 (69.0) | 31 (56.4) | 0.166 |
| Extrahepatic metastasis | 37 (63.8) | 29 (52.7) | 0.233 |
| First-line treatment with lenvatinib† | 23 (39.7) | 20 (36.4) | 0.719 |
| Time on first-line treatment (months) | 7.3 (4.1–12.0) | 7.5 (3.7–14.6) | 0.508 |
| Previous treatment procedures | 0.996 | ||
| Surgery or radical ablation | 15 (25.9) | 14 (25.5) | |
| TACE or HAIC ‡ | 38 (65.5) | 36 (65.5) | |
| Others § | 5 (8.6) | 5 (9.1) | |
| Laboratory test | |||
| α-fetoprotein (ng/mL) | 1087 (19–16,763) | 264 (19–5455) | 0.299 |
| Alanine aminotransferase (U/L) | 30 (21–48) | 37 (28–49) | 0.110 |
| Aspartate aminotransferase (U/L) | 45 (32–83) | 47 (31–67) | 0.927 |
| Total bilirubin (μmol/L) | 13.3 (9.0–20.2) | 14.8 (9.7–25.3) | 0.222 |
| Albumin (g/dL) | 35.4 (31.3–39.4) | 34.7 (32.0–38.9) | 0.508 |
| Lymphocyte (109/L) | 1.05 (0.72–1.49) | 0.91 (0.74–1.33) | 0.373 |
| Neutrophils (109/L) | 2.92 (2.39–3.76) | 2.79 (2.04–4.26) | 0.776 |
| Platelet (109/L) | 143 (102–225) | 113 (84–176) | 0.299 |
| Inflammation-based prognostic score | |||
| NLR | 2.81 (1.92–5.33) | 3.56 (2.01–5.64) | 0.640 |
| PLR | 155 (95–198) | 137 (82–200) | 0.299 |
| Study Center | 0.664 | ||
| Center 1 a | 31 (53.4) | 33 (60.0) | |
| Center 2 b | 15 (25.9) | 14 (25.5) | |
| Center 3 c | 12 (20.7) | 8 (14.5) | |
| Change of α-fetoprotein (%) & | −1.3 (−22.1–39.4) | 12.0 (−18.7–51.6) | 0.346 |
Notes: Categorical data was presented as number (percentage) and quantitative data as median value (Interquartile range). †Sorafenib was as reference. ‡TACE or HAIC without surgery or radical ablation. §Including palliative ablation, radiotherapy, or Iodine 125 seed implantation, without surgery, radical ablation, TACE, or HAIC. aThe Second Affiliated Hospital of Guangzhou Medical University. bJieyang People’s Hospital. cThe First People’s Hospital of Zhaoqing. &Change of α-fetoprotein = (lowest α-fetoprotein level after treatment – baseline α-fetoprotein level)/baseline α-fetoprotein level × 100%.
Abbreviations: rego-sintilimab, regorafenib combined with sintilimab; ECOG, Eastern Cooperative Oncology Group; HBsAg, hepatitis B surface antigen; TACE, transarterial chemoembolization; HAIC, hepatic arterial infusion chemotherapy; PIVKA-II, protein induced by vitamin K absence or antagonist-II; NLR, neutrophil-to-lymphocyte ratio; PLR, platelet-to-lymphocyte ratio.