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A Study on the Combination of Sintilimab, Ramucirumab and Chemotherapy for First-line Treatment of Gastric Cancer With Liver Metastasis

StatusUnknown
PhasePhase 2
Started2024-08
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 28, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Not Yet Recruiting → Unknown
2024-08-26
minor
Study Status, Document Section v1
Trial statusNot Yet Recruiting→Unknown
2024-08-20
minor
Original filing
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.
Trial Details
NCT Number NCT06564298
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Stomach Neoplasms
Enrollment 39 participants
Start Date 2024-08
Primary Completion 2025-12 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2024-08-28