Table 1.
Patient demographics and baseline characteristics (safety population)
| Surufatinib 200 mg QD + toripalimab 240 mg Q3W (n = 6) |
Surufatinib 250 mg QD + toripalimab 240 mg Q3W (n = 12) |
Surufatinib 300 mg QD + toripalimab 240 mg Q3W (n = 12) |
Total (n = 30) |
|
|---|---|---|---|---|
| Age (years) | ||||
| Mean (standard deviation) | 55.2 (13.59) | 55.8 (13.98) | 59.2 (7.61) | 57.0 (11.45) |
| Median | 57.0 | 61.5 | 61.5 | 61.0 |
| Min, max | 36, 74 | 30, 71 | 45, 68 | 30, 74 |
| Sex, n (%) | ||||
| Male | 5 (83.3) | 10 (83.3) | 9 (75.0) | 24 (80.0) |
| Female | 1 (16.7) | 2 (16.7) | 3 (25.0) | 6 (20.0) |
| Race, n (%) | ||||
| Asian | 6 (100.0) | 12 (100.0) | 12 (100.0) | 30 (100.0) |
| BMI (kg/m2) | ||||
| Mean (standard deviation) | 20.83 (3.816) | 25.46 (4.998) | 21.93 (2.918) | 23.12 (4.375) |
| Median | 20.70 | 24.50 | 21.60 | 22.30 |
| Min, max | 15.4, 25.3 | 18.3, 36.9 | 16.3, 27.7 | 15.4, 36.9 |
| Baseline ECOG PS, n (%) | ||||
| 0 | 2 (33.3) | 3 (25.0) | 6 (50.0) | 11 (36.7) |
| 1 | 4 (66.7) | 9 (75.0) | 6 (50.0) | 19 (63.3) |
| Cancer type, n (%) | ||||
| CRC | 0 | 3 (25.0) | 1 (8.3) | 4 (13.3) |
| EC | 0 | 1 (8.3) | 0 | 1 (3.3) |
| GC | 0 | 0 | 2 (16.7) | 2 (6.7) |
| Metastatic squamous cell carcinoma | 0 | 1 (8.3) | 0 | 1 (3.3) |
| NEN | 6 (100.0) | 7 (58.3) | 9 (75.0) | 22 (73.3) |
| NEC | 3 (50.0) | 5 (41.7) | 6 (50.0) | 14 (46.7) |
| NET G2 | 0 | 1 (8.3) | 3 (25.0) | 4 (13.3) |
| NET G3 | 3 (50.0) | 1 (8.3) | 0 | 4 (13.3) |
| Site of primary tumora, n (%) | ||||
| Colon | 0 | 0 | 1 (11.1) | 1 (4.5) |
| Stomach/gastroesophageal junction | 0 (0.0) | 1 (14.3) | 1 (11.1) | 2 (9.1) |
| Lung | 0 | 1 (14.3) | 0 | 1 (4.5) |
| Pancreas | 2 (33.3) | 1 (14.3) | 1 (11.1) | 4 (18.2) |
| Rectum | 2 (33.3) | 0 | 2 (22.2) | 4 (18.2) |
| Stomach | 2 (33.3) | 2 (28.6) | 0 | 4 (18.2) |
| Other | 0 | 1 (14.3) | 3 (33.3) | 4 (18.2) |
| Tumor stage at screening, n (%) | ||||
| IV | 6 (100.0) | 12 (100.0) | 12(100) | 30 (100) |
BMI body mass index, ECOG Eastern Cooperative Oncology Group, PS performance status, CRC colorectal cancer, EC esophageal squamous cell carcinoma, GC gastric cancer, NEC neuroendocrine carcinoma, NET neuroendocrine tumor
aSite of primary tumor was only collected for patients with NENs. The information of site of primary tumor was not recorded in two patients with NEN