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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Sintilimab 200mg iv.gtt d1, every 21 days
Ramucirumab 10mg/kg iv.gtt d1, every 21 days
SOX: Oxaliplatin 130mg/m2 iv.gtt d1, every 21 days and S-1 40mg/m2 po bid d1-14, every 21 days XELOX: Oxaliplatin 130mg/m2 iv.gtt d1, every 21 days and Capecitabine 1000mg/m2 po bid d1-14, every 21 days
Objective Response Rate (ORR)
ORR was defined as the proportion of participants whose tumor volume decreases to a predefined value and can maintain the minimum duration requirements, which is the sum of the rates of Complete Response (CR) and Partial Response (PR) according to RECIST 1.1 based on investigator assessment.
Time frame: Up to approximately 12 months
Disease Control Rate (DCR)
DCR was defined as the percentage of the participants who achieve either a response (PR + CR) or Stable Disease (SD) after treatment and can maintain the minimum duration requirements according to RECIST 1.1 based on investigator assessment.
Time frame: Up to approximately 12 months
Progression-free Survival (PFS)
PFS was defined as the time from the start of treatment to disease progression according to RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.
Time frame: Up to approximately 16 months
Overall Survival (OS)
OS was defined as the time from enrollment to death due to any cause.
Time frame: Up to approximately 16 months
Incidence of adverse events and serious adverse events (AEs)
Categorized according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0). Descriptive statistical analysis is primarily used to list and describe the AEs that occurred during this trial.
Time frame: Up to approximately 16 months
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