EGFR Monoclonal Antibody for Advanced Gastric Cancer

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Shanghai Changzheng Hospital
• Treatments: Antibodies; Antibodies, Monoclonal; Capecitabine; Cetuximab; Fluorouracil; Immunoglobulins; Nimotuzumab; Oxaliplatin

Criteria

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;