Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer
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
| Condition(s) | Gastric Cancer Stage IIIB-IIIC |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * 1\. Subjects voluntarily join the study and sign an informed consent form; 2. Male or female patients between the ages of 18-75; 3. Adenocarcinoma of the gastric/esophagogastric junction after radical resection was staged at stage IIIB-IIIC; 4. The molecular pathology of gastric cancer must meet at least one of the following three conditions: 1. Consistent with high-frequency microsatellite instability MSI-H 2. Consistent with high tumor mutation load TMB-H (≥10 mutations/megabases) 3. High expression of PD-L1 (CPS score ≥5) 5. Expected survival time \> 6 months； 6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points; 7. Have not received anti-tumor immunotherapy; 8. Agree to provide archived tumor tissue samples for molecular testing; 9. Have good organ fu |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Shanghai Minimally Invasive Surgery Center |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2022-07-01 |
| NCT ID | NCT06036745 |
| Official listing | https://clinicaltrials.gov/study/NCT06036745 |