About this trial
it is an an Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination with SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Consistent with high-frequency microsatellite instability MSI-H
Consistent with high tumor mutation load TMB-H (≥10 mutations/megabases)
Hemoglobin ≥90g/L;
Absolute neutrophil count ≥1.5×109/ L;
Disqualifiers
Patients with severe hypertension and poor drug control;
Patients with difficulty in taking oral drugs due to dysphagia, complete or incomplete digestive tract obstruction, active gastrointestinal bleeding, perforation, etc.;
People who are known to be allergic to the ingredients in the test drug or have metabolic disorders;
Simultaneously participating in other tumor experimental drugs or being in other tumor clinical trials.
Trial design
Single group
Treatments tested in this trial
Pembrolizumab + SOX
DrugPembrolizumab 200mg, ivdrip, q3w; Oxaliplatin 135mg/m2, ivdrip,q3w; Trastuzumab 40 mg/m2,po bid,d1\~d14,q21d. Each cycle consists of three weeks, totaling eight cycles
Treatment groups
Trial outcomes
Primary outcomes
Disease-free survival
the time from the start of surgery to the incurable resection, local recurrence or metastasis, or death from any cause.
Secondary outcomes
Overall survival
the time from the start of surgery to death due to any cause.
perioperative complications
perioperative complications
Adverse Events
occurs after a clinical trial subject receives a drug, but is not necessarily causally related to the treatment.
Sponsors and contacts
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