Table 1 Patient demographics
Variables | Dose-escalation part (n = 9) | Expansion part (n = 25) | Total (n = 34) |
|---|---|---|---|
Age | |||
<70 | 8 (88.9%) | 21 (84.0%) | 29 (85.3%) |
≥70 | 1 (11.1%) | 4 (16.0%) | 5 (14.7%) |
Sex | |||
Male | 3 (33.3%) | 17 (68.0%) | 20 (58.8%) |
Female | 6 (66.7%) | 8 (32.0%) | 14 (41.2%) |
BMI, median (range) | 24.5 (22.1–26.3) | 22.2 (17.4–27.7) | 23.3 (17.4–27.7) |
ECOG PS | |||
0 | 0 (0.0%) | 6 (24.0%) | 6 (17.6%) |
1 | 9 (100.0%) | 19 (76.0%) | 28 (82.4%) |
Tumour origin | |||
Gall bladder | 4 (44.4%) | 6 (24.0%) | 10 (29.4%) |
Intrahepatic bile duct | 2 (22.2%) | 8 (32.0%) | 10 (29.4%) |
Extrahepatic bile duct | 2 (22.2%) | 7 (28.0%) | 9 (26.5%) |
Ampulla of Vater | 1 (11.1%) | 4 (16.0%) | 5 (14.7%) |
Disease status | |||
Recurrent | 3 (33.3%) | 11 (44.0%) | 14 (41.2%) |
Initially metastatic | 6 (66.6%) | 14 (56.0%) | 20 (58.8%) |
Metastatic site | |||
Liver | 7 (77.8%) | 14 (56.0%) | 21 (61.8%) |
Distant lymph node | 2 (22.2%) | 12 (48.0%) | 14 (41.2%) |
Peritoneum | 1 (11.1%) | 4 (16.0%) | 5 (14.7%) |
Lung | 1 (11.1%) | 12 (48.0%) | 13 (38.2%) |
Bone | 0 (0.0%) | 3 (12.0%) | 3 (8.8%) |
Othersa | 0 (0.0%) | 2 (8.0%) | 2 (5.9%) |
Operation history | 4 (44.4%) | 17 (68.0%) | 21 (61.8%) |
Chemoradiation history | 2 (22.2%) | 5 (20%) | 7 (20.6%) |
Adjuvant chemotherapy history | 2 (22.2%) | 4 (16.0%) | 6 (17.6%) |
Clinical setting | |||
Palliative second line | 7 (77.8%) | 18 (72.0%) | 25 (73.5%) |
Palliative third line | 2 (22.2%) | 7 (28.0%) | 9 (26.5%) |
Prior fluoropyrimidine exposure | 3 (33.3%) | 9 (36.0%) | 12 (35.3%) |
Prior fluoropyrimidine failure b | 0 (0.0%) | 4 (44.4%) | 4 (33.3%) |
CA 19-9, median (range) | 200 (1–73,400) | 153 (2–72,100) | 157 (1–73,400) |
