A Study of Nimotuzumab Combinated With Gemcitabine in K-RAS Wild-type Locally Advanced and Metastatic Pancreatic Cancer

Inclusion Criteria:

• Age:18-75 years old
• KPS≥60
• Histological or cytological diagnosis that are unsuitable for radical radiotherapy orsurgical treatment of locally advanced or metastatic pancreatic adenocarcinoma (≥6months to the last adjuvant chemotherapy)
• Has at least one objective measurable lesion can be evaluated according to ResponseEvaluation Criteria in Solid Tumors1.1(Helical CT examination of the longest diameterof target lesions≥10mm, such as lymph node metastasis only need the shortest path ≥15mm)
• Life expectancy ≥12 weeks
• K-RAS tumor tissue detected as the wild-type
• Aspartate transaminase（AST）/aminotransferase（ALT）≤2.5×ULN，AST /ALT≤5×ULN（if livermetastases）；Total bilirubin≤2×ULN，Total bilirubin≤3×ULN（if liver metastases）；Absoluteneutrophil count≥1.5×109/L；Blood platelet≥100×109/L；Hemoglobin≥90 g/L；Creatinineclearance≥60ml/min
• Volunteered to participate this study, written informed consent and has a goodcompliance
• Patients of childbearing age and their spouses are willing to take contraceptivemeasures

Exclusion Criteria:

• Before this study had received the following treatments：As a means of anti-tumorpalliative chemotherapy and molecular targeted therapy.Target lesion had receivedradiotherapy without progression.within 4 weeks or be participating in clinical trialsof other therapeutic/ interventionist clinical trial.
• Undergone major surgery within 4 weeks.
• The brain metastasis or leptomeningeal metastasis.
• Has a history of malignancy other than the pancreatic cancer (except for the curedcervix in situ or basal cell carcinoma, and a five-year cure other cancers).
• The merger has symptoms of ascites and requires clinical treatment. Accompanied byother serious disease, including but not limited:Congestive heart failure which isdifficult to control (NYHA III or IV), Unstable angina, Poorly controlled arrhythmia,Uncontrolled moderate to severe hypertension(systolic blood pressure（SBP）>160 mm Hg ordiastolic blood pressure（DBP）>100 mm Hg).Active infection.Diabetes which is difficultto control.Has mental illness which impacts the informed consent and / or complianceprogram.HIV infection.There is serious illness that other researchers consider isunsuitable to participate this study.
• Known allergy to anti-EGFR antibody formulations.