NCT05204173

Efficacy and Safety of Sintilimab Combined Intraperitoneal and Intravenous Paclitaxel Plus Oral S-1 in Gastric Cancer Patients With Peritoneal Metastasis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Gastric Cancer Stage IV
• Peritoneal Metastases

Interventions

Type	Name	Description
DRUG	sintilimab, paclitaxel and S-1	Sintilimab 200mg intravenous (IV) infusion on day 1, PTX 50 mg/m2 IV and PTX 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1 80 mg/m2 for 14 consecutive days with one week rest.

Timeline

• Start date: 2021-05-20
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-01-24
• Last updated: 2022-01-24

Locations

1 site across 1 country: China