Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma

Multi-center Phase II Trial of Nimotuzumab Plus Irinotecan in Patients With High EGFR Expression After Failure of First-line Treatment in Recurrent or Metastatic Gastric Adenocarcinoma（NIEGA）

The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer.

The sample size was calculated using Simon's 2-stage design. The first stage require at least 4 or more out of 19 patients to have a confirmed partial or complete response (assuming P1 = 0.30, P0 = 0.10, with alpha = 0.05 and beta = 0.2) before proceeding to the second stage, in which additional 36 patients were needed. If a total of 15 or more patients achieve a confirmed objective response, then the primary end-point would have been met. The predicted response rate in this study is at least 30%. Blood and tissue samples are required to collect at baseline, response and disease progression.

Inclusion Criteria:

• Advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria:
• Willing to sign ICF
• Above 18 years
• KPS score≥70
• Expected survival time more than 90 days
• Subjects with EGFR overexpression (2+ or 3+ in IHC)
• With target lesions in spiral CT or MRI examination within 30 days
• Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent ,platinum agent and Paclitaxel agent.
• Lab test of baseline meet following criteria
• Hemoglobin higher than 9.0g/dL
• Neutrophil higher than 1,500/mm3
• PLT higher than 10.0 104/mm3
• Bilirubin lower than 1.5 times of upper limit of normal range
• AST,ALT,ALP lower than 2.5 times of upper limit of normal range
• Creatinine lower than upper limit of normal range
• When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range

Exclusion Criteria:

• Patients who have received irinotecan
• Patients who are allergic to irinotecan or nimotuzumab.
• Other active malignancy within the last 5 years
• Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
• Investigator judge not eligible to this trial