Peritoneal Metastases Clinical Trial
Official title:
Efficacy and Safety of Sintilimab Combined Intraperitoneal and Intravenous Paclitaxel Plus Oral S-1 in Gastric Cancer Patients With Peritoneal Metastasis
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.
Gastric cancer patients enrolled in this a phase 2 study received sintilimab (200mg intravenously on day 1), paclitaxel (PTX) (20 mg/m2 intraperitoneally and 50 mg/m2 intravenously on days 1 and 8) plus oral S-1 (80 mg/m2 for 14 consecutive days) every 3 weeks. The primary endpoint is 1-year survival rate. Secondary endpoints are adverse events, R0 resection rate, 3-year overall survival (OS), and 3-year progressive free survival. Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events version 4.0. ;
| NCT number | NCT05204173 |
| Study type | Interventional |
| Source | Ruijin Hospital |
| Contact | Zhongyin Yang, PhD |
| Phone | 8621-64370045 |
| [email protected] | |
| Status | Recruiting |
| Phase | Phase 2 |
| Start date | May 20, 2021 |
| Completion date | December 2023 |
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