Table 1.
Baseline characteristics of study patients
| Sintilimab + chemotherapya (N = 35) | Placebo + chemotherapy (N = 19) | P-value | |
|---|---|---|---|
| Age (years) | |||
| Median | 62 | 63 | 0.69 |
| Range | 41–74 | 44–72 | |
| Sex, n (%) | |||
| Female | 9(25.7) | 7(36.8) | 0.39 |
| Male | 26(74.3) | 12(63.2) | |
| ECOG performance status, n (%) | |||
| 0 | 10(28.6) | 8(42.1) | 0.31 |
| 1 | 25(71.4) | 11(57.9) | |
| Primary tumor location, n (%) | |||
| Gastric | 35(100.0) | 18(94.7) | 0.75 |
| Gastric-esophageal junction | 0(0.0) | 1(5.3) | |
| Histological type, n (%) | |||
| Adenocarcinoma | 25(71.4) | 14(73.7) | 0.86 |
| Signet cell carcinoma | 10(28.6) | 5(26.3) | |
| Lauren’s classification, n (%) | |||
| Intestinal | 6(16.7) | 0(0.0) | 0.2 |
| Diffuse | 5(14.3) | 3(15.8) | |
| Mixed | 2(5.6) | 3(15.8) | |
| Unknown or unclassifiable | 22(62.9) | 13(68.4) | |
| Previous gastrectomy, n (%) | |||
| No | 28(80.0) | 16(84.2) | 0.79 |
| Yes | 7(20.0) | 3(15.8) | |
| Perioperative chemotherapy, n (%) | |||
| No | 31(88.6) | 17(89.5) | 1 |
| Yes | 4(11.4) | 2(10.5) | |
| Extent of disease, n (%) | |||
| Metastatic | 35(100.0) | 16(84.2) | 0.07 |
| Locally advanced | 0(0.0) | 3(15.8) | |
| Site of metastases, n (%) | |||
| Liver | 8(22.9) | 7(36.8) | NA |
| Peritoneum | 14(40.0) | 8(42.1) | |
| Lung | 2(5.7) | 2(10.5) | |
| Bone | 3(8.6) | 1(5.3) | |
| Lymph node | 22(62.9) | 11(57.9) | |
| Other | 8(22.9) | 6(31.6) | |
| Tumor cell PD-L1 expression | |||
| CPS < 10 | 23(65.7) | 14(73.7) | 0.55 |
| CPS ≥ 10 | 12(34.3) | 5(26.3) | |
ECOG Eastern Cooperative Oncology Group, PD-L1 Programmed Death-Ligand 1, CPS the Combined Proportional Score
aChemotherapy: XELOX(Capecitabine plus oxaliplatin)