PD-1 Antibody Adjuvant Therapy for GC Patients With MSI-H After D2 Radical Surgery
Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
Approximately 5% to 10% of gastric cancers have MSI-H/dMMR. According to the results of
retrospective analysis of CLASSIC and MAGIC, MSI-H/dMMR was a good prognosis and potential
negative predictor of adjuvant chemotherapy for resectable gastric cancer. GC patients with
MSI-H/dMMR were relatively insensitive to chemotherapy. The prognosis of these patients
receiving routine postoperative adjuvant chemotherapy was worse than that with surgery alone.
However, these patients were sensitive to immunotherapy. MSI-H/dMMR is one of the most
important biomarkers to predict the efficacy of immunotherapy for GC. In this study, patients
with MSI-H locally advanced gastric adenocarcinoma after radical surgery with D2 dissection
would be randomly treated with conventional adjuvant chemotherapy, PD-1 monoclonal antibody
immunotherapy or follow-up observation. We intend to demonstrate that the prognosis of MSI-H
GC patients after D2 radical gastrectomy receiving PD-1 monoclonal antibody immunotherapy
would be better than that with standard postoperative adjuvant chemotherapy and follow-up
observation.