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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer; Concurrent Chemoradiotherapy

Treatments: Drug: nimotuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01180166

CH-GI-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

nimotuzumab

Experimental group

Description:

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

Treatment:

Drug: nimotuzumab