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Spots Global Cancer Trial Database for PD-1 Antibody Adjuvant Therapy for GC Patients With MSI-H After D2 Radical Surgery

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Trial Identification

Brief Title: PD-1 Antibody Adjuvant Therapy for GC Patients With MSI-H After D2 Radical Surgery

Official Title: PD-1 Antibody Adjuvant Therapy for Patients With MSI-H Advanced Gastric or Gastroesophageal Junction Cancer After Radical Surgery With D2 Dissection: a Phase II Single-center, Three-arm, Randomized Controlled Clinical Trial

Study ID: NCT05468138

Study Description

Brief 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Dazhi Xu, Shanghai, , China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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