Table 1.
Baseline clinical characteristics of patients in the two groups
| Combination group (n = 64) | Control group (n = 71) | p | |
|---|---|---|---|
| Gender | 0.270 | ||
| Male | 42 (65.6) | 40 (56.3) | |
| Female | 22 (34.4) | 31 (43.7) | |
| Age a (year) | 60.0 ± 12.7 | 62.0 ± 12.6 | 0.848 |
| ≥ 65 | 26 (40.6) | 30 (42.3) | |
| < 65 | 38 (59.4) | 41 (57.7) | |
| ECOG performance status + | 0.176 | ||
| 1 | 45 (70.3) | 42 (59.2) | |
| 2 | 19 (29.7) | 29 (40.8) | |
| Primary site of tumour | 0.932 | ||
| Intrahepatic cholangiocarcinoma | 7 (10.9) | 8 (11.3) | |
| Perihilar cholangiocarcinoma | 18 (28.1) | 17 (23.9) | |
| Extrahepatic cholangiocarcinoma | 18 (28.1) | 25 (35.2) | |
| Gallbladder carcinoma | 7 (10.9) | 7 (9.9) | |
| Carcinoma of ampulla | 14 (21.9) | 14 (19.7) | |
| Level of biliary obstruction ‡ | 0.792 | ||
| Common bile or hepatic duct (type I) | 50 (78.1) | 53 (74.6) | |
| Hepatic confluence | |||
| Type II | 0 | 1 (1.4) | |
| Type III (a/b) | 13 (20.3) | 14 (19.7) | |
| Intrahepatic (type IV) | 1 (1.6) | 3 (4.2) | |
| TNM stage | 0.247 | ||
| III | 19 (29.7) | 30 (42.3) | |
| IV | 43 (67.2) | 38 (53.5) | |
| Distant metastasis | 0.117 | ||
| Yes | 23 (35.9) | 35 (49.3) | |
| No | 41 (64.1) | 36 (50.7) | |
| Obstructive length a(cm) | 3.9 ± 1.6 | 3.8 ± 1.1 | 0.375 |
| ≥ 4 | 31 (48.4) | 29 (40.8) | |
| < 4 | 33 (51.6) | 42 (59.2) | |
| Previous treatment | |||
| Surgical resection | 10 (15.6) | 9 (12.7) | 0.623 |
| Radiotherapy | 4 (6.3) | 3 (4.2) | 0.888 |
| Adjuvant chemotherapy | 1 (1.6) | 5 (7.0) | 0.261 |
| Preoperative total bilirubin a(μ mol/L) | 291.7 ± 129.6 | 297.3 ± 118.4 | 0.850 |
| CA125 (U/mL) | 0.359 | ||
| > 40 | 31 (48.4) | 40 (56.3) | |
| ≤ 40 | 33 (51.6) | 31 (43.7) | |
| CA19-9 (U/mL) | 0.582 | ||
| > 40 | 57 (89.1) | 61 (85.9) | |
| ≤ 40 | 7 (10.9) | 10 (14.1) | |
| Infected markers | |||
| WBC (×109/L ) | 0.227 | ||
| > 8 | 34 (53.1) | 45 (63.4) | |
| ≤ 8 | 30 (46.9) | 26 (36.6) | |
aData are medians ± standard deviation
+According to the Toxicity and response criteria of the Eastern Cooperative Oncology Group
‡According to the Bismuth classification of perihilar cholangiocarcinoma
Unless otherwise indicated, data are number of patients and data in parentheses are percentages
HAIC, hepatic artery infusion chemotherapy; CA125/19-9, carbohydrate antigen 125/19-9; WBC, white blood cell count