drugset / Trial / NCT03745170
Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to estimate overall survival of Sintilimab+ oxaliplatin + capecitabine and placebo+ oxaliplatin + capecitabine, as first-line treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Timeline
- Start
- 2018-12-19
- Primary completion
- 2021-06-20
- Completion
- 2022-10-21
Publications
- Wu H, Shu W, Ding Y, Li Q, Li N, Wang Q, Chen Y, Han Y, Huang D, Jiang H. The immune signatures predict gastric/gastroesophageal junction cancer response to first-line anti-PD-1 blockade or chemotherapy. BMC Cancer. 2025 Aug 25;25(1):1369. doi: 10.1186/s12885-025-14805-6.
- Li W, Wan L. Cost-utility of sintilimab plus chemotherapy vs chemotherapy as first-line treatment of advanced gastric or gastroesophageal junction cancer in China. Expert Rev Pharmacoecon Outcomes Res. 2024 Jun;24(5):671-678. doi: 10.1080/14737167.2024.2341859. Epub 2024 Apr 11.
- Xu J, Jiang H, Pan Y, Gu K, Cang S, Han L, Shu Y, Li J, Zhao J, Pan H, Luo S, Qin Y, Guo Q, Bai Y, Ling Y, Yang J, Yan Z, Yang L, Tang Y, He Y, Zhang L, Liang X, Niu Z, Zhang J, Mao Y, Guo Y, Peng B, Li Z, Liu Y, Wang Y, Zhou H; ORIENT-16 Investigators. Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial. JAMA. 2023 Dec 5;330(21):2064-2074. doi: 10.1001/jama.2023.19918.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sintilimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |