A Study on the Combination of Sintilimab, Ramucirumab and Chemotherapy for First-line Treatment of Gastric Cancer With Liver Metastasis
Summary
The goal of this clinical trial is to observe the efficacy and safety of Sintilimab (a PD-1 inhibitor) combined with Ramucirumab (a VEGFR-2 antagonist) and chemotherapy as a first-line treatment for patients with advanced gastric cancer with liver metastasis. * Can the combination of Sintilimab, Ramucirumab, and chemotherapy improve the prognosis of patients with AGC and liver metastases? * What are the adverse events (AEs) associated with the use of the combination regimen of Sintilimab, Ramucirumab, and chemotherapy in patients with AGC and liver metastases? Participants will: * Receive a combined treatment regimen of Sintilimab, Ramucirumab, and chemotherapy (SOX (oxaliplatin and S-1) or XELOX (oxaliplatin and capecitabine)), administered every 21 days for up to 6 cycles. Following the completion of 6 cycles, maintenance therapy with Sintilimab and oral chemotherapy agents (capecitabine or S-1) with or without Ramucirumab will be administered until disease progression. * Imaging assessments will be performed at baseline, after every 2 cycles of treatment, and every 3 months following the completion of 6 cycles of treatment.
Timeline
- Start
- 2024-08
- Primary completion
- 2025-12
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Ramucirumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | S-1 | Small molecule | 40 mg/m2 | Oral |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |