drugset / Trial / NCT05204173
Efficacy and Safety of Sintilimab Combined Intraperitoneal and Intravenous Paclitaxel Plus Oral S-1 in Gastric Cancer Patients With Peritoneal Metastasis
NaSingle-groupOpen-labelTreatment
Summary
In this phase 2 study, we combined sintilimab, paclitaxel and S-1 as regimen to treat gastric cancer patients with peritoneal metastasis. We are aim to estimate the efficacy and safety of this regimen in the phase 2 study.
Timeline
- Start
- 2021-05-20
- Primary completion
- 2023-12
- Completion
- 2023-12
Publications
- Yuan H, Lu S, Sun DB, Yao XX, Liu WT, Zheng YN, Hua ZC, Ni ZT, He CY, Wang ZQ, Zhang J, Liu D, Jiang C, Li C, Zhang J, Yan M, Yang ZY, Shi M, Zhu ZG, Yan C. Intraperitoneal and intravenous paclitaxel plus S-1 and sintilimab as first-line treatment for gastric cancer with peritoneal metastasis: a single-arm phase 2 trial (DRAGON-09). EClinicalMedicine. 2025 Dec 29;91:103731. doi: 10.1016/j.eclinm.2025.103731. eCollection 2026 Jan.
- Yuan H, Lu S, Shi M, Yang Z, Liu W, Ni Z, Yao X, Hua Z, Feng R, Zheng Y, Wang Z, Sah BK, Chen M, Zhu Z, He C, Li C, Zhang J, Yan C, Yan M, Zhu Z. Sintilimab combined neoadjuvant intraperitoneal and systemic chemotherapy in gastric cancer with peritoneal metastasis. Future Oncol. 2023 Dec;19(38):2517-2523. doi: 10.2217/fon-2022-0738. Epub 2023 May 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 50 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 80 mg/m2 | Oral |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |