Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer

• Status: Unknown status
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of these treatment need to be further analyzed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Capecitabine; Nimotuzumab

Criteria

Inclusion Criteria:

• 18-75 years old, male or female

• Gastric cancer with measurable lesions, and the diameter is at least 1 cm

• Karnofsky score: at least 70

• Estimated survival: at least 6 months

• No prior target therapy or radiotherapy

• No severe hypertension, cardiac disease, or diabetes mellitus

• Normal blood routine and chemical tests

• Signed consent

Exclusion Criteria:

• Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer

• Extensive distant metastases

• Pregnancy or in lactation

• Allergic to 5-Fluorouracil