EGFR Monoclonal Antibody for Advanced Gastric Cancer

A Study of EGFR Monoclonal Antibody (Cetuximab/Nimotuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With EGFR-amplification Advanced Gastric Cancer

This study is intended to evaluate efficacy and safety of EGFR monoclonal antibody (Cetuximab/Nimotuzumab) in combination with a chemotherapy in gastric cancer patients with EGFR amplification.

This parallel, randomized, open-label, single-centre study will evaluate the effect on overall survival of EGFR monoclonal antibody (Cetuximab/Nimotuzumab) in combination with a chemotherapy compared to the chemotherapy alone in patients with EGFR-amplication advanced gastric cancer. Cetuximab will be administered as intravenous infusion of 500 mg/m2 (BSA) every 3 weeks, while nimotuzumab will be administered as intravenous infusion of 400mg every week. The chemotherapy consists of a combination of 12 cycles of mFOLFOX-6, 6-8 cycles of SOX, 6-8 cycles of CapOX. Treatment with cetuximab/nimotuzumab will continue until disease progression. The target sample size is 50-100 patients.

Inclusion Criteria:

• Adult patients >=18 years of age
• Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction Adenocarcinoma
• EGFR-Amplification tumors (Copy Number>=5 for tissue or blood Next Generation Sequence)
• Expected survival ≥ 3 month;
• ECOG / PS score: 0-2;
• the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min;

Exclusion Criteria:

• Previous chemotherapy for advanced/metastatic disease;
• Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome;
• History of cardiac disease;
• Dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy;
• Patient can not comply with research program requirements or follow-up;