Gastric Cancer Clinical Trial
Official title:
Trastuzumab Plus XELOX for HER2-positive Stage III Gastric Cancer After D2 Gastrectomy：Prospective Observational Study.
The objective of this study is to assess the clinical efficacy and safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.
Gastric cancer is the second leading cause of cancer death worldwide. Highest incidence rate
is observed in Eastern Asia.
D2 gastrectomy has been established as a standard surgical procedure. While recurrence rate
after resection is still high.
The CLASSIC study showed that Xelox regimen after D2 gastrectomy improves 3-year
disease-free survival compared with surgery only. But patients with late stage still have
poor prognosis according to subgroup analysis and our retrospective study.
HER2 is an important biomarker and key driver of tumorigenesis in 7-34% gastric cancers. The
ToGA study showed that trastuzumab, a monoclonal antibody that targets HER2, plus
chemotherapy improved overall survival(16.0m vs 11.8m) in patients with HER2-positive
advanced gastric or gastro-oesophageal junction cancer.
Based on previous experiences of trastuzumab in adjunctive therapy of breast cancer and
ACTS/CLASSIC/ToGA studies, we suppose that trastuzumab plus XELOX as adjunctive treatment
may benefit patients with HER2-positive Stage III gastric cancer after D2 Gastrectomy.
According to the above, we do this single-arm research to assess the clinical efficacy and
safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer
After D2 Gastrectomy.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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