A Phase 2 interventional study of SOX and XELOX in MSI-H, PD-1 Immunotherapy and Gastric Cancer, sponsored by Fudan University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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.
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 94 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
8 cycles of adjuvant SOX or XELOX should be performed within 8 weeks after receiving standard gastrectomy with D2 lymphadenectomy. SOX: S-1：40\~60mg bid，d1\~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W 8 cycles (6 months) XELOX: capecitabine：1000 mg/m2 ，bid, d1\~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W 8 cycles (6 months)
Drug: SOX · Drug: XELOX
Adjuvant treatment with PD-1 antibody every 3 weeks(maximum 1 years) should be performed within 8 weeks after receiving standard gastrectomy with D2 lymphadenectomy. PD-1 antibody: Sintilimab at a dose of 200 mg every 3 weeks for 16 cycles or Nivolumab at a dose of 360 mg every 3 weeks for 16 cycles
Drug: PD-1 antibody
Drug: Tegafur-Gimeracil-Oteracil Potassium The dose of S-1 is according to body-surface area (BSA): patients with a BSA of less than 1.25 m2 received 80 mg daily; those with a BSA of 1.25 m2 or more but less than 1.5 m2 received 100 mg daily; and those with a BSA of 1.5 m2 or more received 120 mg daily. oxaliplatin 130mg/m2, intravenously, on day 1. Drug: Oxaliplatin The dose of oxaliplatin is according to body-surface area (BSA): 130mg/m2, intravenously, on day 1.
Drug: Capecitabine 1000mg/m2, orally, twice per day, from day 1 to day 14, Q3W. Drug: Oxaliplatin The dose of oxaliplatin is according to body-surface area (BSA): 130mg/m2, intravenously, on day 1.
Sintilimab at a dose of 200 mg every 3 weeks for 16 cycles or Nivolumab at a dose of 360 mg every 3 weeks for 16 cycles
3 year Disease Free Survival
3-year DFS
Time frame: 3 years
morbidity
safety of PD1 antibody therapy
Time frame: 1 year
mortality
safety of PD1 antibody therapy
Time frame: 1 year
adverse events during PD1 therapy
safety of PD1 antibody therapy
Time frame: 1 year
5 year Overall Survival
5-year OS
Time frame: 5 years
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fudan University