Table 1 Baseline characteristics of patients
Baseline characteristics | Placebo n = 68 | Thymostimulin n = 67 |
|---|---|---|
Patients | ||
Male/female (%) | 82/18 | 84/16 |
Median age (years (range)) | 63 (39-76) | 63 (48-79) |
Median body weight (kg (range)) | 80 (39-108) | 79 (58-112) |
Mean Karnofsky score (% (range)) | 87 (60-100) | 89 (60-100) |
Cause of liver disease (%) | ||
Alcohol abuse | 47 | 55 |
HBV/HCV | 21 | 18 |
Other | 32 | 27 |
Stage of liver disease (%) | ||
Liver cirrhosis | 90 | 85 |
Child classification: A or no cirrhosis/B/C | 63/28/9 | 65/32/3 |
Tumor stage (%) | ||
Okuda stage I/II/III | 32/56/12 | 35/54/11 |
CLIP score 0/1/2/3/4-6 | 0/18/35/25/22 | 0/15/29/29/27 |
BCLC stage A/B/C/D | 0/16/69/15 | 0/22/66/12 |
α-FP (%) | ||
< 400 ng/ml | 57 | 57 |
> 400 ng/ml | 43 | 43 |
Tumor characteristics (%) | ||
Ascites | 46 | 37 |
Portal vein thrombosis | 32 | 42 |
Multifocal tumor manifestation | 88 | 91 |
Extrahepatic metastases | 40 | 45 |
Hepato-renal laboratory parameters | ||
Mean urea (mg/dl [95% CI]) | 4.3 [2.8-5.8] | 3.7 [2.8-4.5] |
Mean creatinine (mg/dl [95% CI]) | 0.4 [0.3-0.6] | 0.5 [0.4-0.6] |
Mean sodium (mmol/l [95% CI]) | 137 [136-138] | 137 [136-138] |
Mean albumin (g/l [95% CI]) | 27 [23-31] | 29 [26-32] |
Previous treatment (%) (combination possible) | ||
none | 68 | 72 |
Surgery | 15 | 9 |
Percutaneous ethanol injection (PEI) | 4 | 2 |
Transarterial chemoembolisation (TACE) | 25 | 20 |
Systemic hormone- and/or chemotherapy | 12 | 9 |