NCT02380131

Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Herceptin in Patients With Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hebei Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Stage I：preoperative therapy * Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage II: Perioperative therapy * Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis;

Detailed description

The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with herceptin to improves R0 resection rate and survival among patients with potentially resectable HER-2 positive gastric cancer with liver metastasis.

Conditions

• HER-2 Positive Gastric Cancer
• Liver Metastasis

Interventions

Type	Name	Description
DRUG	Oxaliplatin plus Capecitabine	A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles.
DRUG	Herceptin	Herceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 cycles.

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-03-05
• Last updated: 2015-03-05

Locations

1 site across 1 country: China