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

Phase 2

• Conditions: Gastric Cancer; Concurrent Chemoradiotherapy
• Interventions: Drug: nimotuzumab

• Registration Number: NCT01180166
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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.

Detailed Description

There is no standard treatment for patients with inoperable locally advanced or residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine chemoradiotherapy showed similar results. So far, more and more studies have shown that drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II studies. Because of poor survival of patients with inoperable locally advanced or residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine chemoradiotherapy need to be further analyzed.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-17
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nimotuzumab	nimotuzumab	Combination of nimotuzumab and capecitabine concurrent chemoradiotherapy is received by patients.

Primary Outcome Measures

Name	Time	Method
progression-free survival	1 year progression-free survival	progression-free survival: the time between tumor regression to progression

Secondary Outcome Measures

Name	Time	Method
overall responses	1 month after treatment	the overall responses: complete response (CR)+ partial response(PR)+ stable disease (SD) rates based on World Health Organization(WHO) evaluation system
overall survival time	1 month after treatment	median overall survival time

Trial Locations

Locations (1)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China