NCT02250209

T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy

Trastuzumab Plus XELOX for HER2-positive Stage III Gastric Cancer After D2 Gastrectomy：Prospective Observational Study.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab	Trastuzumab is given by intravenous infusion at 440mg on day 0every 3 weeks. Number of cycles: 14\~16 cycles.
DRUG	Capecitabine	Capecitabine 800\~1000 mg/m² is given orally twice a day for 14 days followed by a 1-week rest. Number of cycles: 8 cycles.
DRUG	Oxaliplatin	Oxaliplatin is given by intravenous infusion at 130 mg/m2 on day 1 every 3 weeks. Number of cycles: 8 cycles.

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2014-09-26
• Last updated: 2014-09-26

Locations

1 site across 1 country: China