Nab-paclitaxel plus capecitabine as first-line treatment for advanced biliary tract cancers: An open-label, non-randomized, phase II clinical trial

Table 1 Basic demographic characteristics, n (%)

Characteristic	Total (n = 44)
Age, years (median, IQR)	64.00 (35.00, 76.00)
Sex
Male	18 (40.91)
Female	26 (59.09)
ECOG performance
0	25 (56.82)
1	19 (43.18)
Tumor subtype
Gallbladder cancer	20 (45.45)
Intrahepatic cholangiocarcinoma	11 (25.00)
Extrahepatic cholangiocarcinoma	13 (29.55)
Number of metastatic sites
No metastasis	3 (6.82)
Single	21 (47.73)
Multiple	20 (45.45)
Metastatic sites
Liver	20 (45.45)
Lung	5 (11.36)
Peritoneum	9 (20.45)
Previous antitumor therapy
Radical resection	26 (59.09)
Adjuvant systemic therapy	7 (15.91)
Stage
III	1 (2.27)
IV	40 (90.91)
Uncertain	3 (6.82)
Baseline CA199
< 37 U/mL	16 (36.36)
≥ 37 U/mL	28 (63.64)

ECOG: Eastern Cooperative Oncology Group; CA199: Carbohydrate antigen 199; IQR: Interquartile range.

Table 2 Treatment response in patients, n (%)

Therapeutic response assessment	Evaluable patients (n = 43)
Objective response rate (95%CI)	10 (23.26) (11.80-38.60)
Complete response	2 (4.65)
Partial response	8 (18.60)
Stable disease	20 (46.51)
Progressive disease	13 (30.23)
Disease control rate (95%CI)	30 (69.77) (53.90-82.80)
Progression-free survival (95%CI, months)	4.4 (2.5-6.3)
Overall survival (95%CI, months)	14.1 (8.3-19.9)

CI: Confidence interval.

Table 3 Treatment response in patients with gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma

	ORR	DCR	OS (95%CI)	PFS (95%CI)
GBC	25.00 (11.19-46.87)	70.00 (48.10-85.45)	8.5 (2.3-14.8)	4.1 (2.1-5.9)
ICC	18.18 (5.14-47.70)	72.73 (43.44-90.25)	11.2 (5.2-17.3)	5.3 (2.0-8.5)
ECC	25.00 (8.89-53.23)	66.67 (39.06-86.19)	15.6 (3.9-27.2)	5.1 (0.0-11.0)

GBC: Gallbladder cancer; ICC: Intrahepatic cholangiocarcinoma; ECC: Extrahepatic cholangiocarcinoma; ORR: Objective response rate; DCR: Disease control rate; OS: Overall survival; PFS: Progression-free survival; CI: Confidence interval.

Table 4 Adverse events occurring in ≥ 10% of the patients, n (%)

Adverse event	Grade 1-2	Grade 3-4	All grades
Alopecia	35 (79.50)	0 (0.00)	35 (79.50)
Leukopenia	22 (50.00)	2 (4.55)	24 (54.55)
Neutropenia	19 (43.18)	4 (9.09)	23 (52.27)
Liver dysfunction	18 (40.91)	0 (0.00)	18 (40.91)
Hyperbilirubinemia	16 (36.36)	2 (4.55)	18 (40.91)
Anemia	14 (31.81)	2 (4.55)	16 (36.36)
Neurotoxicity	10 (22.71)	2 (4.55)	12 (27.27)
ST-T abnormal change	9 (20.45)	0 (0.00)	9 (20.45)
Sinus tachycardia	6 (13.64)	0 (0.00)	6 (13.64)
Anorexia	5 (11.36)	0 (0.00)	5 (11.36)