Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer
Conditions
Gastric Cancer - Concurrent Chemoradiotherapy
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric cancer, concurrent chemoradiotherapy, target therapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: nimotuzumab
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China
Status: Recruiting
Contact: Ningning Lu, Doctor - +86 01087788280 - ykyzlyy@hotmail.com
Start Date
May 2010
Completion Date
September 2013
Sponsors
Chinese Academy of Medical Sciences
Source
Chinese Academy of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page