Gastric Cancer Clinical Trial
Official title:
A Phase 2 Study of Trastuzumab in Combination With TS-ONE and Cisplatin in First-line Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer.
The investigators hypothesis is that the combination of TS-ONE with cisplatin and trastuzumab is safe and as effective as combination treatment for HER2 positive gastric cancer.
Gastric carcinoma is the second most common cause of cancer death world-wide. Approximately
875,000 patients are diagnosed world-wide with gastric cancer each year. Gastric cancer is
often diagnosed at an advanced stage1. At diagnosis, while some patients have gastric
carcinoma that extends within loco-regional confines and can undergo a curative resection,
many patients cannot undergo curative resection. Gastric cancer continues to pose a major
medical challenge.
While advanced gastric carcinoma is incurable, chemotherapy can have a palliative effect in
symptomatic patients. Chemotherapy improves outcome compared to best supportive care in
gastric cancer. Various chemotherapeutic agents including 5-FU, mitomycin, etoposide,
cisplatin, irinotecan and the taxanes, have demonstrated activity as monotherapy.
Combination chemotherapy has been shown to have better survival outcomes than single agent
chemotherapy Standard chemotherapy for advanced gastric carcinoma includes a
fluoropyrimidine and platinum -based combination chemotherapy.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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